Invasive AspergillosisPRISMANCT04550936
A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.
An observational study of Invasive Aspergillosis and Mucormycosis, run by Pfizer at 15 sites in 5 countries.
Trial summary
This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Aspergillosis, Mucormycosis
- What is being tested?
- Isavuconazole
- How many people
- 307 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 10 Mar 2021to 23 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who received isavuconazole for the treatment of invasive aspergillosis or mucormycosis in the hospital setting in five European countries (France, Germany, Italy, Spain, and the United Kingdom).
Who may be able to join
- Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
- Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )
- Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)
Who cannot join
- 1. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Spain5 sites
Vall d'Hebron University Hospital
Barcelona, 08035
Fundació Clínic Per A La Recerca Biomèdica
Barcelona, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Marques de Valdecilla
Santander, 39011
University Hospital Miguel Servet
Zaragoza, 50009
Germany4 sites
University Hospital of Cologne
Cologne, 50937
Universitätsklinik Frankfurt
Frankfurt, 60590
Klinikum rechts der Isar Technische Universität München
Munich, 81675
Comprehensive Cancer Center Ulm (CCCU)
Ulm, 89081
France3 sites
CHU de Limoges
Limoges, 87042
Paris University
Paris, 75015
Institut de Cancérologie
Strasbourg, 67033
United Kingdom2 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
King'S College Hospital Nhs Foundation Trust
London, SE5 9RS
Italy1 site
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
About this study
Official title: Patterns of Real-World Isavuconazole Use, Effectiveness, Safety, and Healthcare Resource Utilization-a Retrospective Chart Review Study of Patients With Mucormycosis or Invasive Aspergillosis (PRISMA)
This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
Read the detailed description
This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting.
Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first.
De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.
- Conditions
- Invasive Aspergillosis, Mucormycosis
- Being tested
- Isavuconazole
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsavuconazoleDrug
Also called Cresemba
antifungal agent
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response at Week 6
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Clinical Response at Week 12
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Clinical Response at Week 24
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Radiological Response at Week 6
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Radiological Response at Week 12
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: >= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Radiological Response at Week 24
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: >= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Mycological Response at Week 6
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Mycological Response at Week 12
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Mycological Response at Week 24
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
All-Cause Mortality at Week 6
Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
All-Cause Mortality at Week 12
Number of participants who died due to any cause at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
All-Cause Mortality at Week 24
Number of participants who died due to any cause at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Adverse Event at Week 6
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Adverse Event at Week 12
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Adverse Event at Week 24
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Serious Adverse Event at Week 6
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Serious Adverse Event at Week 12
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Serious Adverse Event at Week 24
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Secondary outcomes (22)
Number of Participants According to Method of Administration
Number of participants according to method of drug administration: infusion, oral and unknown were reported in this outcome measure.
Measured: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Number of Participants According to Dosage of Isavuconazole Administration
Number of participants according to dosage of drug administration: 200 milligram (mg), other and unknown were reported in this outcome measure.
Measured: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Number of Participants With Therapeutic Drug Monitoring (TDM)
Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Isavuconazole Treatment Modification
Treatment modification was defined as change in dose or dosing schedule of participants who received isavuconazole. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Types of Isavuconazole Treatment Modification
Number of participants with type of treatment modifications required during the index period were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment and Treatment Modification
Duration between Isavuconazole treatment and treatment modification was defined as the date of first modification minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Percentage of Participants Who Discontinued Isavuconazole Treatment
Percentage of participants who discontinued Isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration of Isavuconazole Treatment
Duration between Isavuconazole treatment was defined as the date of discontinuation minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Number of participants with reasons for Isavuconazole treatment discontinuation were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants Who Switched to New Antifungal
Number of participants who switched to new antifungal therapy after discontinuation of Isavuconazole were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Type of New Antifungal Therapy
Number of participants according to new antifungal therapy after end of isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Isavuconazole Administered as Part of Combination Therapy
Number of participants with index treatment administered as part of antifungal combination therapy were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. one participant could have received more than one treatment
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants Who Received Other Concomitant Treatments
Concomitant treatments included: Antibiotic agent, corticosteroid agent, chemotherapy, immunosuppressant agent, other and unknown were reported in this outcome measure. One participant could have more than one treatment. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Any Outpatient Visits
Number of participants with any outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Total Number of Outpatient Visits
Total number of outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Type of Outpatient Visits
Type of outpatient visit (Health Care Professional Visit or Referral) such as secondary care visit (specialist), secondary care referral (specialist), primary care visit (general practitioner) and emergency room (ER) visit were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit
Duration between Isavuconazole treatment was defined as the date of first outpatient visit minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Inpatient Hospitalization
Number of participants according to index treatment administered in the inpatient setting were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Primary Reason For Inpatient Hospitalization
Number of participants with primary reason for inpatient hospitalization such as other disease monitoring, other, invasive aspergillosis or mucormycosis disease monitoring, AE related to invasive aspergillosis or mucormycosis and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization
Duration between Isavuconazole treatment was defined as the date of inpatient hospitalization minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Mean Length of Stay For Inpatient Hospitalization
Length of stay was computed as the date of discharge from hospital minus the date of hospitalization plus (+) 1. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants According to Location for Inpatient Hospitalization
Number of participants according to location for inpatient hospitalization such as: hematology ward, other ward, intensive care unit, transplantation ward, emergency room, general medicine ward, oncology ward and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Measured: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start10 Mar 2021
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550936
- Sponsor's protocol ID
- C3791008
- Other IDs
- NCT04550936
- Acronym
- PRISMA
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2020
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Neofytos D, Pagliuca A, Houghton K, Broughton E, de Figueiredo Valente MLN, Jiang L, Enoch DA, Gruener B, Herbrecht R, Lahmer T, Lortholary O, Melenotte C, De Rosa FG, Garcia-Vidal C, Jimenez M, Fernandez M, Cornely O. Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019). Infect Dis Ther. 2024 Dec;13(12):2527-2543. doi: 10.1007/s40121-024-01064-4. Epub 2024 Oct 24.
PubMed 39443403
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Real-World Isavuconazole Use, Effectiveness, Safety, and Healthcare Resource Utilization-a Retrospective Chart Review Study of Patients With Mucormycosis or Invasive Aspergillosis (PRISMA)
- ClinicalTrials.gov ID
- NCT04550936
- Acronym / sponsor ID
- PRISMA / C3791008
- Conditions
- Invasive Aspergillosis, Mucormycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
Detailed description
This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting.
Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first.
De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who received isavuconazole for the treatment of invasive aspergillosis or mucormycosis in the hospital setting in five European countries (France, Germany, Italy, Spain, and the United Kingdom).
Key inclusion criteria (3 listed)
- Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
- Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )
- Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)
Key exclusion criteria (1 listed)
- 1. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsavuconazoleAlso: Cresembaantifungal agent | Drug | – |
Primary outcome
Number of Participants With Clinical Response at Week 6
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Clinical Response at Week 12
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Clinical Response at Week 24
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Radiological Response at Week 6
Time frame: Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Radiological Response at Week 12
Time frame: Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: >= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Radiological Response at Week 24
Time frame: Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: >= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Mycological Response at Week 6
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Mycological Response at Week 12
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Mycological Response at Week 24
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
All-Cause Mortality at Week 6
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
All-Cause Mortality at Week 12
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of participants who died due to any cause at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
All-Cause Mortality at Week 24
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of participants who died due to any cause at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Adverse Event at Week 6
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Adverse Event at Week 12
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Adverse Event at Week 24
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Serious Adverse Event at Week 6
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Serious Adverse Event at Week 12
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Number of Participants With Serious Adverse Event at Week 24
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
22 secondary outcomes
Number of Participants According to Method of Administration
Time frame: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Number of Participants According to Dosage of Isavuconazole Administration
Time frame: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Number of Participants With Therapeutic Drug Monitoring (TDM)
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Isavuconazole Treatment Modification
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Types of Isavuconazole Treatment Modification
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment and Treatment Modification
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Percentage of Participants Who Discontinued Isavuconazole Treatment
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration of Isavuconazole Treatment
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants Who Switched to New Antifungal
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Type of New Antifungal Therapy
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Isavuconazole Administered as Part of Combination Therapy
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants Who Received Other Concomitant Treatments
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Any Outpatient Visits
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Total Number of Outpatient Visits
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Type of Outpatient Visits
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Inpatient Hospitalization
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Primary Reason For Inpatient Hospitalization
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Mean Length of Stay For Inpatient Hospitalization
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants According to Location for Inpatient Hospitalization
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39443403Neofytos D, Pagliuca A, Houghton K, Broughton E, de Figueiredo Valente MLN, Jiang L, Enoch DA, Gruener B, Herbrecht R, Lahmer T, Lortholary O, Melenotte C, De Rosa FG, Garcia-Vidal C, Jimenez M, Fernandez M, Cornely O. Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019). Infect Dis Ther. 2024 Dec;13(12):2527-2543. doi: 10.1007/s40121-024-01064-4. Epub 2024 Oct 24.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Aspergillosis and Mucormycosis, run by Pfizer at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Germany, France, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Response at Week 6 (time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.