InfectionEZTEAMNCT03923426
Real-World Observational Study Of Zavicefta to Characterize Use Patterns
An observational study of Infection, run by Pfizer at 45 sites in 11 countries.
Trial summary
This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Zavicefta Treatment
- How many people
- 572 participants
- Where
- 45 sitesin 11 countries
- Study dates
- 27 Nov 2018to 28 Mar 2022
- 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: Hospitalized patients with ≥72 hours of exposure to ceftazidime-avibactam at 42 European sites. Patients will be identified over a 12-month period and information about treatment will be abstracted from medical records after treatment completion. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal, or loss-to-follow-up, whichever occurs first.
Who may be able to join
- Hospitalized patient ≥18 years old or considered an adult in accordance with the age of majority in the participant's country of residence at the time of treatment with ceftazidime-avibactam.
- Patient received ≥1 dose of ceftazidime-avibactam in routine practice at participating site since 01 January, 2018 onwards or since the date of launch in the country if it is after 01 January, 2018.
- Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification).
- Patient has all required essential data elements which include:
- Start and stop dates of ceftazidime-avibactam,
- Start and stop dates of prior antibiotic therapy used for the index infection,
- Type of combined antibiotic therapy (if applicable) and start and stop dates of any antibiotic combined with ceftazidime-avibactam.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study where required by local regulations.
Who cannot join
- Patients must not meet any of the following exclusion criteria to be eligible:
- The patient is enrolled in any clinical trial of an investigational product. Patients who are enrolled in non-interventional studies (NISs) (e.g. registries) are eligible for inclusion.
- The patient has received ceftazidime-avibactam in a compassionate care program setting.
- The patient was exposed to ceftazidime-avibactam before use for the index infection.
Trial locations and contacts
45 sites in 11 countries.
45 sites in 11 countries
Argentina6 sites
Hospital Aleman
Buenos Aires
Hospital Britanico de Buenos Aires
CABA, 1280
CEMIC
Ciudad Autonoma Buenos Aires, 1436
Hospital Italiano
Ciudad Autonoma Buenos Aires
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba
Sanatorio Britanico S.A.
Rosario, 2000
Russia6 sites
Regional Clinical Hospital #1
Krasnodar, 350000
SBIH of Moscow City Clinical Hospital # 7
Moscow, 115446
FSBI "State Scientific Centre of Coloproctology" of the MoH of RF
Moscow, 123154
FSBI "Hematological Research Center" MoH of RF
Moscow, 125167
North-West Federal Medical Research Center n.a. V.A. Almazov
Saint Petersburg, 197341
SBIH Republican Clinical Hospital n.a. G. G. Kuvatov
Ufa, 450000
Brazil5 sites
Hospital Felício Rocho
Belo Horizonte, 30110-934
Hospital Vera Cruz
Belo Horizonte, 30140-030
CEPETI - Centro de Estudos e Pesquisa em Emergências Médicas e Terapia Intensiva
Curitiba, 82530200
Hospital Moinho de Ventos
Porto Alegre, 90035-004
Hospital de Caridade de Santa Maria -HCAA
Santa Maria, 97105-900
France5 sites
CHU Angers - Hôpital Hôtel Dieu
Angers, 49100
CHU Nantes - Hôtel Dieu pt
Nantes, 44093
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
Hôpital Bichat - Claude Bernard
Paris, 75018
Centre Hospitalier de Tourcoing
Tourcoing, 59208
Italy5 sites
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138
Azienda Ospedaliero Universitaria San Martino
Genoa, 16132
Azienda Ospedaliera Universitaria Pisana
Pisa, 56100
Policlinico Universitario Agostino Gemelli
Rome, ROMA, 00168
Ospedale Amedeo di Savoia
Torino, 10149
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge
Barcelona, 08207
Hospital Universitario Reina Sofía
Córdoba, 14004
Hopsital Ramón y Cajal
Madrid, 28034
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36312
Colombia4 sites
Centro médico Imbanaco
Cali
Caja de Compensacion Familiar de Caldas / Confa
Manizales, 170003
Promotora Medica Las Americas SA
Medellín, 050025
IPS Universitaria
Medellín, 2644
United Kingdom4 sites
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Chelsea and Westminster Hospital
London, SW10 9NH
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT
Sheffield Teaching Hospitals
Sheffield, South Yorkshire, S5 7AU
Germany2 sites
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590
University Hospital Jena
Jena, 07747
Greece2 sites
General Hospital of Athens Laiko
Athens, Attica, 11527
University of Patras Medical School
Pátrai, Achaia, 26504
About this study
Official title: REAL-WORLD OBSERVATIONAL STUDY OF ZAVICEFTA (REGISTERED) (CEFTAZIDIME-AVIBACTAM) TO CHARACTERIZE USE PATTERNS, EFFECTIVENESS AND SAFETY - EZTEAM STUDY
This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. 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 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam.
Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurs first.
Data will be abstracted from medical records using an electronic case report form (eCRF). Baseline data include patient socio-demographics, medical history, and clinical and microbiological characteristics of the infection treated.
Follow-up data will include details of treatment over time and clinical, microbiological, and healthcare resource utilization outcomes.
Evaluation of clinical success will be performed in patients with at least ≥72 hours of exposure to ceftazidime-avibactam.
Safety will be evaluated in all patients exposed to at least one dose of the product.
- Conditions
- Infection
- Being tested
- Zavicefta Treatment
- Keywords
- ceftazidime-avibactam, Zavicefta
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zavicefta TreatmentOther
Non-interventional - Retrospective Chart Review
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population
Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure. Index date was start date of ceftazidime-avibactam.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population
Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure.
Measured: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population
The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population
The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.
Measured: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
Number of participants classified according to frequency of dose (once daily [OD], every other day [QOD], post-dialysis, each 48 hours [h], three times daily [TID], twice daily [BD], four times daily [QID], once loading dose [an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose], every three days, once, etc.,) for ceftazidime-avibactam were reported in this outcome measure.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
Number of participants classified according to frequency of dose (once daily [OD], every other day [QOD], each 48 hours [h], continuous infusion per 48 hours [c/48 h], three times daily [TID], twice daily [BD], four times daily [QID], one dose, loading dose [an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose] etc.,) for ceftazidime-avibactam were reported in this outcome measure.
Measured: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population
Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population
Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.
Measured: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.
Measured: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
The number of participants classified according to antibiotics used concurrently with ceftazidime-avibactam were reported in this outcome measure. Participants could have received more than 1 antibiotic.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
The number of participants classified according to reason for initiating specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for initiating antibiotics.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
The number of participants classified according to reason for discontinuing specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for discontinuing antibiotics.
Measured: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population
The number of participants whose samples were taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure.
Measured: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
The number of participants classified according to the type of specimen taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure. More than 1 type of specimen could have been taken from 1 participant.
Measured: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
The number of participants classified according to the pathogens identified from the microbiological culture after treatment initiation were reported in this outcome measure.
Measured: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
The number of gram-negative pathogens according to the susceptibility to specific antibiotics after treatment initiation were reported in this outcome measure.
Measured: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Multi-drug resistance was defined as the isolate being non-susceptible to at least one agent in more than or equal to (>=) 3 antimicrobial categories, excluding the therapeutic classes to which the pathogen was intrinsically resistant. The number of gram-negative pathogens classified according to the antibiotic resistance to specified antibiotics after treatment initiation were reported in this outcome measure.
Measured: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Measured: At initial hospitalization (from the data evaluated in approximately 40 months of this study)
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Measured: 60 days after hospital discharge (from the data evaluated in approximately 40 months of this study)
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Measured: 60 days post treatment (from the data evaluated in approximately 40 months of this study)
Number of Participants With Microbiological Treatment Outcome as Success: MOD Population
The number of participants with microbiological treatment outcome as success were reported in this outcome measure. Success was defined as: absence of causative pathogen from appropriately obtained specimens at the site of infection.
Measured: Up to 14 days post first dose of ceftazidime-avibactam (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population
The number of participants classified according to antibiotics used (Yes or No) for current infection before ceftazidime-avibactam were reported in this outcome measure.
Measured: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
The number of participants classified according to reason for discontinuing for prior antibiotic therapy were reported in this outcome measure. One participant could have more than 1 reason of discontinuation for prior antibiotic therapy.
Measured: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
Percentage of Participants Who Died During Index Hospitalization
In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure.
Measured: During index hospitalization, maximum of 418 days (from the data evaluated in approximately 40 months of this study)
Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
30-day mortality was defined as deaths occurred from index treatment up to within 30 days after hospital discharge including in-hospital mortality.
Measured: From index treatment up to 30 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
60-day mortality was defined as deaths occurred from index treatment up to within 60 days after hospital discharge including in-hospital mortality.
Measured: From index treatment up to 60 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. AE included both SAEs and non-SAEs. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. Only AEs and SAEs with explicit attribution to ceftazidime-avibactam that appeared in the reviewed information and scenarios involving drug exposure to ceftazidime-avibactam, which included exposure during pregnancy, exposure during breastfeeding, medication error, overdose, misuse, extravasation, lack of efficacy and occupational exposure associated with the use of ceftazidime-avibactam were collected in the study.
Measured: From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Duration of Hospital Stay: FAS72+ Population
Hospital length of stay (LOS) was defined as date of hospital discharge minus date of hospital admission plus 1. The duration of hospital stay of participants were reported in this outcome measure.
Measured: From index date up to hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Total Duration of ICU Stay: FAS72+ Population
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The total duration of ICU stay of participants were reported in this outcome measure.
Measured: During index hospitalization, maximum up to 418 days (from the data evaluated in approximately 40 months of the study)
Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population
The number of participants readmitted to the hospital during the 30 days after initial discharge were reported in this outcome measure.
Measured: Up to 30 days after initial discharge (from the data evaluated in approximately 40 months of the study)
Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population
The number of participants readmitted to the hospital during the 60 days after initial discharge were reported in this outcome measure.
Measured: Up to 60 days after initial discharge (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
The number of participants classified according to the reason for readmission to the hospital were reported in this outcome measure. One participant could have more than 1 reason for readmission to the hospital.
Measured: At readmission to the hospital, up to maximum of 60 days post initial hospital discharge (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
The number of participants classified according to the healthcare resource utilization during the hospitalization were reported in this outcome measure. One participant could have utilized more than 1 healthcare resource during hospitalization.
Measured: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
The number of participants classified according to all wards attended during hospitalization were reported in this outcome measure.
Measured: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start27 Nov 2018
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
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 InfectionStudies 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
- 572 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
- NCT03923426
- Sponsor's protocol ID
- C3591031
- Other IDs
- EZTEAM STUDY
- Acronym
- EZTEAM
- Status last verified
- Jan 2024
- First submitted
- 18 Apr 2019
- Last updated
- 21 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Soriano A, Montravers P, Bassetti M, Klyasova G, Daikos G, Irani P, Stone G, Chambers R, Peeters P, Shah M, Hulin C, Albuquerque N, Basin E, Gaborit B, Kourbeti I, Menichetti F, Perez-Rodriguez MT, Pletz MW, Sanchez M, Trompa I, Verma A, de Figueiredo MLN, Charbonneau C. The Use and Effectiveness of Ceftazidime-Avibactam in Real-World Clinical Practice: EZTEAM Study. Infect Dis Ther. 2023 Mar;12(3):891-917. doi: 10.1007/s40121-023-00762-9. Epub 2023 Feb 10.
PubMed 36763243
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REAL-WORLD OBSERVATIONAL STUDY OF ZAVICEFTA (REGISTERED) (CEFTAZIDIME-AVIBACTAM) TO CHARACTERIZE USE PATTERNS, EFFECTIVENESS AND SAFETY - EZTEAM STUDY
- ClinicalTrials.gov ID
- NCT03923426
- Acronym / sponsor ID
- EZTEAM / C3591031
- Conditions
- Infection
- Keywords
- ceftazidime-avibactam, Zavicefta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Posted 18 Dec 2023
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 treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. 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 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam.
Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurs first.
Data will be abstracted from medical records using an electronic case report form (eCRF). Baseline data include patient socio-demographics, medical history, and clinical and microbiological characteristics of the infection treated.
Follow-up data will include details of treatment over time and clinical, microbiological, and healthcare resource utilization outcomes.
Evaluation of clinical success will be performed in patients with at least ≥72 hours of exposure to ceftazidime-avibactam.
Safety will be evaluated in all patients exposed to at least one dose of the product.
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
- Hospitalized patients with ≥72 hours of exposure to ceftazidime-avibactam at 42 European sites. Patients will be identified over a 12-month period and information about treatment will be abstracted from medical records after treatment completion. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal, or loss-to-follow-up, whichever occurs first.
Key inclusion criteria (8 listed)
- Hospitalized patient ≥18 years old or considered an adult in accordance with the age of majority in the participant's country of residence at the time of treatment with ceftazidime-avibactam.
- Patient received ≥1 dose of ceftazidime-avibactam in routine practice at participating site since 01 January, 2018 onwards or since the date of launch in the country if it is after 01 January, 2018.
- Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification).
- Patient has all required essential data elements which include:
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study where required by local regulations.
Key exclusion criteria (4 listed)
- The patient is enrolled in any clinical trial of an investigational product. Patients who are enrolled in non-interventional studies (NISs) (e.g. registries) are eligible for inclusion.
- The patient has received ceftazidime-avibactam in a compassionate care program setting.
- The patient was exposed to ceftazidime-avibactam before use for the index infection.
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 |
|---|---|---|
| Zavicefta TreatmentNon-interventional - Retrospective Chart Review | Other | – |
Primary outcome
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure. Index date was start date of ceftazidime-avibactam.
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure.
Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.
Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of participants classified according to frequency of dose (once daily [OD], every other day [QOD], post-dialysis, each 48 hours [h], three times daily [TID], twice daily [BD], four times daily [QID], once loading dose [an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose], every three days, once, etc.,) for ceftazidime-avibactam were reported in this outcome measure.
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of participants classified according to frequency of dose (once daily [OD], every other day [QOD], each 48 hours [h], continuous infusion per 48 hours [c/48 h], three times daily [TID], twice daily [BD], four times daily [QID], one dose, loading dose [an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose] etc.,) for ceftazidime-avibactam were reported in this outcome measure.
Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.
Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Time frame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to antibiotics used concurrently with ceftazidime-avibactam were reported in this outcome measure. Participants could have received more than 1 antibiotic.
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to reason for initiating specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for initiating antibiotics.
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to reason for discontinuing specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for discontinuing antibiotics.
Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population
Time frame: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
The number of participants whose samples were taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure.
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Time frame: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to the type of specimen taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure. More than 1 type of specimen could have been taken from 1 participant.
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Time frame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to the pathogens identified from the microbiological culture after treatment initiation were reported in this outcome measure.
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Time frame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
The number of gram-negative pathogens according to the susceptibility to specific antibiotics after treatment initiation were reported in this outcome measure.
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Time frame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
Multi-drug resistance was defined as the isolate being non-susceptible to at least one agent in more than or equal to (>=) 3 antimicrobial categories, excluding the therapeutic classes to which the pathogen was intrinsically resistant. The number of gram-negative pathogens classified according to the antibiotic resistance to specified antibiotics after treatment initiation were reported in this outcome measure.
Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
Time frame: At initial hospitalization (from the data evaluated in approximately 40 months of this study)
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
Time frame: 60 days after hospital discharge (from the data evaluated in approximately 40 months of this study)
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
Time frame: 60 days post treatment (from the data evaluated in approximately 40 months of this study)
The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.
Number of Participants With Microbiological Treatment Outcome as Success: MOD Population
Time frame: Up to 14 days post first dose of ceftazidime-avibactam (from the data evaluated in approximately 40 months of the study)
The number of participants with microbiological treatment outcome as success were reported in this outcome measure. Success was defined as: absence of causative pathogen from appropriately obtained specimens at the site of infection.
Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population
Time frame: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
The number of participants classified according to antibiotics used (Yes or No) for current infection before ceftazidime-avibactam were reported in this outcome measure.
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Time frame: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
The number of participants classified according to reason for discontinuing for prior antibiotic therapy were reported in this outcome measure. One participant could have more than 1 reason of discontinuation for prior antibiotic therapy.
Percentage of Participants Who Died During Index Hospitalization
Time frame: During index hospitalization, maximum of 418 days (from the data evaluated in approximately 40 months of this study)
In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure.
Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
Time frame: From index treatment up to 30 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
30-day mortality was defined as deaths occurred from index treatment up to within 30 days after hospital discharge including in-hospital mortality.
Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
Time frame: From index treatment up to 60 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
60-day mortality was defined as deaths occurred from index treatment up to within 60 days after hospital discharge including in-hospital mortality.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. AE included both SAEs and non-SAEs. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. Only AEs and SAEs with explicit attribution to ceftazidime-avibactam that appeared in the reviewed information and scenarios involving drug exposure to ceftazidime-avibactam, which included exposure during pregnancy, exposure during breastfeeding, medication error, overdose, misuse, extravasation, lack of efficacy and occupational exposure associated with the use of ceftazidime-avibactam were collected in the study.
Duration of Hospital Stay: FAS72+ Population
Time frame: From index date up to hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Hospital length of stay (LOS) was defined as date of hospital discharge minus date of hospital admission plus 1. The duration of hospital stay of participants were reported in this outcome measure.
Total Duration of ICU Stay: FAS72+ Population
Time frame: During index hospitalization, maximum up to 418 days (from the data evaluated in approximately 40 months of the study)
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The total duration of ICU stay of participants were reported in this outcome measure.
Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population
Time frame: Up to 30 days after initial discharge (from the data evaluated in approximately 40 months of the study)
The number of participants readmitted to the hospital during the 30 days after initial discharge were reported in this outcome measure.
Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population
Time frame: Up to 60 days after initial discharge (from the data evaluated in approximately 40 months of the study)
The number of participants readmitted to the hospital during the 60 days after initial discharge were reported in this outcome measure.
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
Time frame: At readmission to the hospital, up to maximum of 60 days post initial hospital discharge (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to the reason for readmission to the hospital were reported in this outcome measure. One participant could have more than 1 reason for readmission to the hospital.
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Time frame: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to the healthcare resource utilization during the hospitalization were reported in this outcome measure. One participant could have utilized more than 1 healthcare resource during hospitalization.
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
Time frame: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
The number of participants classified according to all wards attended during hospitalization were reported in this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36763243Soriano A, Montravers P, Bassetti M, Klyasova G, Daikos G, Irani P, Stone G, Chambers R, Peeters P, Shah M, Hulin C, Albuquerque N, Basin E, Gaborit B, Kourbeti I, Menichetti F, Perez-Rodriguez MT, Pletz MW, Sanchez M, Trompa I, Verma A, de Figueiredo MLN, Charbonneau C. The Use and Effectiveness of Ceftazidime-Avibactam in Real-World Clinical Practice: EZTEAM Study. Infect Dis Ther. 2023 Mar;12(3):891-917. doi: 10.1007/s40121-023-00762-9. Epub 2023 Feb 10.
- 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
45 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Pfizer at 45 sites in 11 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 8 inclusion and 4 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Argentina, Russia, Brazil, France, Italy and 6 more countries. 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 18 Dec 2023). 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 Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population (time frame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)). The study lists 35 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 NCT03923426, 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 21 Jun 2024.