PhotochemotherapyNCT04047914
Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients
A study testing Antimicrobial Photodynamic therapy and Mupirocin ointment in people with Photochemotherapy and Renal Insufficiency, Chronic, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of this study will be to evaluate the effect of Antimicrobial Photodynamic Therapy (aPDT) in the Nasal Decolonization of Dialytic Chronic Renal Patients, Staphylococcus Aureus (S.aureus) Carriers This is a 3-months follow-up, randomized, single-blind, prospective controlled trial, single-center and will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photochemotherapy, Renal Insufficiency, Chronic
- What is being tested?
- Antimicrobial Photodynamic therapy and Mupirocin ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2019to 12 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nasal carriers of S.aureus
- chronic kidney patient undergoing hemodialysis treatment;
- aged over 18 years;
- both genders;
Who cannot join
- pregnancy or breastfeeding;
- presence of nasal foreign body;
- history of nasal surgery in the last 3 months;
- active infection by S. aureus;
- use of topical nasal or systemic antibiotic in the last three months;
- history of severe allergy to mupirocin or methylene blue (MB);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial
The objective of this study will be to evaluate the effect of Antimicrobial Photodynamic Therapy (aPDT) in the Nasal Decolonization of Dialytic Chronic Renal Patients, Staphylococcus Aureus (S.aureus) Carriers This is a 3-months follow-up, randomized, single-blind, prospective controlled trial, single-center and will happen in 02 phases: Phase 1 - Epidemiological Evaluation - A researcher will invite the research participants who are undergoing treatment at the Hemodialysis Service of Clinical Hospital and explain its contents. After reading and signing the informed consent, this same researcher (calibrated for the experiment) will perform nasal secretion microbiological collections to identify patients colonized by S.aureus in the anterior nostril (nasal carrier) - baseline T0 and the application of the questionnaire that identifies possible factors that may be considered as risk for colonization and possible development of diseases related to S. aureus. In the laboratory of Microbiology, the strains will be identified and the colonized patients will be invited to continue the study (Phase 2). Non-carrier patients will only be counseled with infection prevention care. Phase 2 - Parallel clinical trial with two intervention groups (aPDT or Mupirocin) - Patients with nasal aureus (thirty-four colonized patients aged over 18 years) will be treated with aPDT (experimental group) or mupirocin (control group). A trained researcher will collect new aliquots of nasal discharge after completion of nostril treatment (T1) to check for decolonization by culture. A new collection will be performed at 1 (T2) and 3 (T3) months after treatment to assess recolonization. It was evaluated intervention safety (photodynamic therapy) through a directed and open questionnaire about adverse effects.
Read the detailed description
Infections are the leading cause of morbidity and the second leading cause of mortality among patients with chronic kidney disease (CKD) on renal replacement therapy. Staphylococcus aureus (S. aureus) is a major agent and previous nasal colonization represents an independent risk factor for infection. Up to 50% of these patients can be known to be colonized. With the global increase in bacterial resistance by S.aureus strategies for infection prevention and transmission by this agent are needed. The strategy of decolonization and elimination of nasal carrier status by S.aureus in dialytic chronic renal patients reduces infection rates, especially bacteremia. The gold standard for nasal decolonization is topical mupirocin treatment, but there are reports of increasing resistance especially after prolonged use, which limits the establishment of clinical protocols for the prevention of infection in the dialysis population. Antimicrobial Photodynamic Therapy (aPDT) proves to be a promising approach for its potential bactericidal effect, including multidrug-resistant bacteria and its low tendency to induce drug resistance.
This is a 3-months follow-up, randomized, single-blind, prospective controlled trial, single-center and will happen in 02 phases: Phase 1 - Epidemiological Evaluation - A researcher will invite the research participants who are undergoing treatment at the Hemodialysis Service of Clinical Hospital and explain its contents. After reading and signing the informed consent, this same researcher (calibrated for the experiment) will perform nasal secretion microbiological collections to identify patients colonized by S.aureus in the anterior nostril (nasal carrier) - baseline T0 and the application of the questionnaire that identifies possible factors that may be considered as risk for colonization and possible development of diseases related to S. aureus. In the laboratory of Microbiology, the strains will be identified and the colonized patients will be invited to continue the study (Phase 2). Non-carrier patients will only be counseled with infection prevention care. Phase 2 - Parallel clinical trial with two intervention groups (aPDT or Mupirocin) - Patients with nasal aureus (thirty-four colonized patients aged over 18 years) will be treated with aPDT (experimental group) or mupirocin (control group). Two other trained researchers will collect new aliquots of nasal discharge after completion of nostril treatment (T1) to check for decolonization by culture. A new collection will be performed at 1 (T2) and 3 (T3) months after treatment to assess recolonization.It was evaluated intervention safety (photodynamic therapy) through a directed and open questionnaire about adverse effects,immediately after treatments, with a 3-month follow-up.
- Conditions
- Photochemotherapy, Renal Insufficiency, Chronic
- Being tested
- Antimicrobial Photodynamic therapy, Mupirocin ointment
- Keywords
- antimicrobial photodynamic therapy, Staphylococcus aureus, nasal decolonization, hemodialysis, chronic kidney disease, mupirocin
- Medical subject headings
- Renal Insufficiency, Chronic, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Photodynamic therapyDevice
Also called Photochemotherapy
Application 0.01% methylene blue with sterile swabs in each nostril with a 10-minute pre-irradiation
- Light-emitting diode (λ = 660 nm), for 300 seconds, with an irradiance of 400 mW / cm2
Mupirocin ointmentDrug
Also called Mupirocin Nasal Product
Performed with 2% Mupirocin Ointment, to be applied to the anterior nostrils twice a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| experimental aPDT group | Experimental | Application of 0.01% methylene blue with enough sterile swab to cover the inner nostril extension with a 10 minute pre-irradiation time. The irradiations were carried out with a red light-emitting diode (LED) (λ = 660 nm), for 300 seconds, irradiance of 400 mW / cm2, radiant exposure 124 J / cm2, with uniform application in each anterior nostril. Receives: Device: Antimicrobial Photodynamic therapy |
| control mupirocin group | Active comparator | A standard treatment will be performed conventionally with topical mupirocin. Will be performed with 2% Mupirocin Ointment, to be applied to the anterior nostrils twice a day for 5 days. Receives: Drug: Mupirocin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin
The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Fligh
Measured: Before the intervention (T0)
Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin
The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Fligh
Measured: Immediately after the completion of treatments (T1)
Secondary outcomes (4)
Prevalence of S.aureus
To evaluate the prevalence of both sensitive and methicillin-resistant S.aureus patients by bacterial culture and antibiogram in patients with renal chronic disease on dialysis treatment at the Hemodialysis Service of the University of São Paulo Medical School of Sao Paulo.
Measured: initial screening time to assess nasal staphylococcus aureus carrier before treatments
Prevalence of recolonization
To evaluate the prevalence of recolonization by Staphylococcus aureus in the anterior nostril in through qualitative microbiological culture (presence or absence). The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Flight.
Measured: 01 and 03 months after treatments
Anamnesis and risk factor collection
Guiding questions were applied to all patients. In addition to questions related to the patient's general health, demographic data (age, gender, marital status, occupation, education, housing), medical history data (etiology of CKD ( renal chronic disease), comorbidities, time of dialysis treatment until protocol initiation, presence smoking rate, type of venous access and time of use, kidney transplantation, systemic antibiotic therapy in the last 12 months, hospitalization or infection (including skin) in the last 12 months).
Measured: immediately after recruiting and accepting patients who met the inclusion/exclusion criteria
Ontervention safety: photodynamic therapy
The analysis of adverse effects through a directed and open questionnaire, especially for this study
Measured: immediately after treatments, with a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Nov 2019
- Primary completion15 Jan 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PhotochemotherapyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 34 individuals will be randomly divided into 2 groups: G1 - Experimental Group (n = 17) - Treatment will be performed with methylene blue and red light-emitting diode (LED) in the nostrils. G2 - Control group (n = 17) - Standard treatment will be performed conventionally with topical mupirocin.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Anna Carolina RT Horliana, phD, Principal investigator, Nove de Julho UniversityDaniella T Bezerra, phD, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047914
- Sponsor's protocol ID
- NASAL DECOLONIZATION
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu XJ, Fang Y, Yao M. Antimicrobial photodynamic therapy for methicillin-resistant Staphylococcus aureus infection. Biomed Res Int. 2013;2013:159157. doi: 10.1155/2013/159157. Epub 2013 Feb 28.
PubMed 23555074Wertheim HF, Melles DC, Vos MC, van Leeuwen W, van Belkum A, Verbrugh HA, Nouwen JL. The role of nasal carriage in Staphylococcus aureus infections. Lancet Infect Dis. 2005 Dec;5(12):751-62. doi: 10.1016/S1473-3099(05)70295-4.
PubMed 16310147Tacconelli E, Carmeli Y, Aizer A, Ferreira G, Foreman MG, D'Agata EM. Mupirocin prophylaxis to prevent Staphylococcus aureus infection in patients undergoing dialysis: a meta-analysis. Clin Infect Dis. 2003 Dec 15;37(12):1629-38. doi: 10.1086/379715. Epub 2003 Nov 20.
PubMed 14689344Bezerra DT, La Selva A, Cecatto RB, Deana AM, Prates RA, Bussadori SK, Mesquita-Ferrari RA, Motta LJ, Fernandes KPS, Martimbianco ALC, Frochot C, Pereira BJ, Rossi F, Mimica MJ, Horliana ACRT. Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial. Am J Kidney Dis. 2023 May;81(5):528-536.e1. doi: 10.1053/j.ajkd.2022.09.013. Epub 2022 Nov 14.
PubMed 36396084
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT04047914
- Acronym / sponsor ID
- NASAL DECOLONIZATION
- Conditions
- Photochemotherapy, Renal Insufficiency, Chronic
- Keywords
- antimicrobial photodynamic therapy, Staphylococcus aureus, nasal decolonization, hemodialysis, chronic kidney disease, mupirocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study will be to evaluate the effect of Antimicrobial Photodynamic Therapy (aPDT) in the Nasal Decolonization of Dialytic Chronic Renal Patients, Staphylococcus Aureus (S.aureus) Carriers This is a 3-months follow-up, randomized, single-blind, prospective controlled trial, single-center and will happen in 02 phases: Phase 1 - Epidemiological Evaluation - A researcher will invite the research participants who are undergoing treatment at the Hemodialysis Service of Clinical Hospital and explain its contents. After reading and signing the informed consent, this same researcher (calibrated for the experiment) will perform nasal secretion microbiological collections to identify patients colonized by S.aureus in the anterior nostril (nasal carrier) - baseline T0 and the application of the questionnaire that identifies possible factors that may be considered as risk for colonization and possible development of diseases related to S. aureus. In the laboratory of Microbiology, the strains will be identified and the colonized patients will be invited to continue the study (Phase 2). Non-carrier patients will only be counseled with infection prevention care. Phase 2 - Parallel clinical trial with two intervention groups (aPDT or Mupirocin) - Patients with nasal aureus (thirty-four colonized patients aged over 18 years) will be treated with aPDT (experimental group) or mupirocin (control group). A trained researcher will collect new aliquots of nasal discharge after completion of nostril treatment (T1) to check for decolonization by culture. A new collection will be performed at 1 (T2) and 3 (T3) months after treatment to assess recolonization. It was evaluated intervention safety (photodynamic therapy) through a directed and open questionnaire about adverse effects.
Detailed description
Infections are the leading cause of morbidity and the second leading cause of mortality among patients with chronic kidney disease (CKD) on renal replacement therapy. Staphylococcus aureus (S. aureus) is a major agent and previous nasal colonization represents an independent risk factor for infection. Up to 50% of these patients can be known to be colonized. With the global increase in bacterial resistance by S.aureus strategies for infection prevention and transmission by this agent are needed. The strategy of decolonization and elimination of nasal carrier status by S.aureus in dialytic chronic renal patients reduces infection rates, especially bacteremia. The gold standard for nasal decolonization is topical mupirocin treatment, but there are reports of increasing resistance especially after prolonged use, which limits the establishment of clinical protocols for the prevention of infection in the dialysis population. Antimicrobial Photodynamic Therapy (aPDT) proves to be a promising approach for its potential bactericidal effect, including multidrug-resistant bacteria and its low tendency to induce drug resistance.
This is a 3-months follow-up, randomized, single-blind, prospective controlled trial, single-center and will happen in 02 phases: Phase 1 - Epidemiological Evaluation - A researcher will invite the research participants who are undergoing treatment at the Hemodialysis Service of Clinical Hospital and explain its contents. After reading and signing the informed consent, this same researcher (calibrated for the experiment) will perform nasal secretion microbiological collections to identify patients colonized by S.aureus in the anterior nostril (nasal carrier) - baseline T0 and the application of the questionnaire that identifies possible factors that may be considered as risk for colonization and possible development of diseases related to S. aureus. In the laboratory of Microbiology, the strains will be identified and the colonized patients will be invited to continue the study (Phase 2). Non-carrier patients will only be counseled with infection prevention care. Phase 2 - Parallel clinical trial with two intervention groups (aPDT or Mupirocin) - Patients with nasal aureus (thirty-four colonized patients aged over 18 years) will be treated with aPDT (experimental group) or mupirocin (control group). Two other trained researchers will collect new aliquots of nasal discharge after completion of nostril treatment (T1) to check for decolonization by culture. A new collection will be performed at 1 (T2) and 3 (T3) months after treatment to assess recolonization.It was evaluated intervention safety (photodynamic therapy) through a directed and open questionnaire about adverse effects,immediately after treatments, with a 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 34 individuals will be randomly divided into 2 groups: G1 - Experimental Group (n = 17) - Treatment will be performed with methylene blue and red light-emitting diode (LED) in the nostrils. G2 - Control group (n = 17) - Standard treatment will be performed conventionally with topical mupirocin.
| Arm | Type | Receives |
|---|---|---|
| experimental aPDT group | Experimental | Device: Antimicrobial Photodynamic therapyApplication of 0.01% methylene blue with enough sterile swab to cover the inner nostril extension with a 10 minute pre-irradiation time. The irradiations were carried out with a red light-emitting diode (LED) (λ = 660 nm), for 300 seconds, irradiance of 400 mW / cm2, radiant exposure 124 J / cm2, with uniform application in each anterior nostril. |
| control mupirocin group | Active comparator | Drug: Mupirocin ointmentA standard treatment will be performed conventionally with topical mupirocin. Will be performed with 2% Mupirocin Ointment, to be applied to the anterior nostrils twice a day for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- nasal carriers of S.aureus
- chronic kidney patient undergoing hemodialysis treatment;
- aged over 18 years;
- both genders;
Key exclusion criteria (6 listed)
- pregnancy or breastfeeding;
- presence of nasal foreign body;
- history of nasal surgery in the last 3 months;
- active infection by S. aureus;
- use of topical nasal or systemic antibiotic in the last three months;
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 |
|---|---|---|
| Antimicrobial Photodynamic therapyAlso: PhotochemotherapyApplication 0.01% methylene blue with sterile swabs in each nostril with a 10-minute pre-irradiation • Light-emitting diode (λ = 660 nm), for 300 seconds, with an irradiance of 400 mW / cm2 | Device | experimental aPDT group |
| Mupirocin ointmentAlso: Mupirocin Nasal ProductPerformed with 2% Mupirocin Ointment, to be applied to the anterior nostrils twice a day for 5 days. | Drug | control mupirocin group |
Primary outcome
Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin
Time frame: Before the intervention (T0)
The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Fligh
Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin
Time frame: Immediately after the completion of treatments (T1)
The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Fligh
4 secondary outcomes
Prevalence of S.aureus
Time frame: initial screening time to assess nasal staphylococcus aureus carrier before treatments
Prevalence of recolonization
Time frame: 01 and 03 months after treatments
Anamnesis and risk factor collection
Time frame: immediately after recruiting and accepting patients who met the inclusion/exclusion criteria
Ontervention safety: photodynamic therapy
Time frame: immediately after treatments, with a 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 23555074Fu XJ, Fang Y, Yao M. Antimicrobial photodynamic therapy for methicillin-resistant Staphylococcus aureus infection. Biomed Res Int. 2013;2013:159157. doi: 10.1155/2013/159157. Epub 2013 Feb 28.
- Results publication: PubMed 16310147Wertheim HF, Melles DC, Vos MC, van Leeuwen W, van Belkum A, Verbrugh HA, Nouwen JL. The role of nasal carriage in Staphylococcus aureus infections. Lancet Infect Dis. 2005 Dec;5(12):751-62. doi: 10.1016/S1473-3099(05)70295-4.
- Results publication: PubMed 14689344Tacconelli E, Carmeli Y, Aizer A, Ferreira G, Foreman MG, D'Agata EM. Mupirocin prophylaxis to prevent Staphylococcus aureus infection in patients undergoing dialysis: a meta-analysis. Clin Infect Dis. 2003 Dec 15;37(12):1629-38. doi: 10.1086/379715. Epub 2003 Nov 20.
- Derived from this study: PubMed 36396084Bezerra DT, La Selva A, Cecatto RB, Deana AM, Prates RA, Bussadori SK, Mesquita-Ferrari RA, Motta LJ, Fernandes KPS, Martimbianco ALC, Frochot C, Pereira BJ, Rossi F, Mimica MJ, Horliana ACRT. Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial. Am J Kidney Dis. 2023 May;81(5):528-536.e1. doi: 10.1053/j.ajkd.2022.09.013. Epub 2022 Nov 14.
- Individual participant dataSharing planned: No
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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.
Anna Carolina RT Horliana, phD principal investigator
Nove de Julho University
Daniella T Bezerra, phD principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial Photodynamic therapy and Mupirocin ointment in people with Photochemotherapy and Renal Insufficiency, Chronic, run by University of Nove de Julho at 1 site in Brazil.
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 4 inclusion and 6 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin (time frame: Before the intervention (T0)). The study lists 2 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 NCT04047914, which also lists 4 linked publications.
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 3 Jul 2023.