Community-Acquired Pneumonia (CAP)NCT06782282
A Study to Learn About How Well the Prevnar 20 Vaccine Works for Pneumonia in People Who Are 65 Years and Older
An observational study of Community-Acquired Pneumonia (CAP), run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease (a group of severe infections caused by a bacteria called Streptococcus pneumoniae), pneumococcal pneumonia (a bacterial lung disease caused by the germ Streptococcus pneumoniae), all-cause pneumonia… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-Acquired Pneumonia (CAP)
- Type of treatment
- Vaccines
- How many people
- 22,234,435 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Aged ≥65 years, residing in one of the 50 US states or in Washington, D.C., continuously enrollmed in Medicare FFS Parts A and B for 365 days prior to the index date, allowing for gaps of ≤45 days (baseline period)
Patients from the Medicare database to be included in the analysis must be:
- aged 65 or older as of 28Jan22 (date of 20-valent pneumococcal conjugate vaccine (PCV20)
- residing in one of the 50 US states or Washington DC
- be continuously enrolled in Medicare Fee for Service Parts A and B for 365 days prior to the index date allowing for gaps of up to 45 days (baseline period)
Patients from the Medicare database will be excluded from the analysis if:
- there is a record of death prior to the index date
- the patient was enrolled in Medicare Part C at any point between 28Jan22 and the index date
- the patient received PCV20 before 01Jul22
- the patient received PCV15 prior to the index date
- sex information is missing
If the patient received the pneumococcal polysaccharide vaccine (PPSV23) within 2 years prior to index date, the corresponding time segment (ie 2 years prior to index date) will be excluded.
If the patient received PCV13 within the past 5 years prior to the index date, the corresponding time segment (ie 5 years prior to index date) will be excluded. However, those who received PCV13 more than 5 years prior to index date will still have all data included in primary analyses.
For PCV20 period, exclude those when IPD, PP, ACP or LRTI outcome incurred between PCV20 vaccination date and prior to the index date (a 30-day blackout period).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Effectiveness of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) Among Medicare Fee-for-service Beneficiaries Aged ≥65 Years in the United States
The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease (a group of severe infections caused by a bacteria called Streptococcus pneumoniae), pneumococcal pneumonia (a bacterial lung disease caused by the germ Streptococcus pneumoniae), all-cause pneumonia (pneumonia caused by any germ including bacteria, a virus, or a fungus), and lower respiratory tract infection (infection of the lower airways in the lung) in people 65 years and older.
This study will use a database of people who have Medicare insurance with names and other identifying information removed. This study will include people who:
Read more
- are 65 years and older,
- live in one of the 50 United States or Washington DC, and
- are enrolled in Medicare Fee-for-Service Parts A and B for at least 1 year.
The study uses data that is already being collected and no treatment or vaccine will be given in the study.
People that fit the description above will be followed in the Medicare database for about two years. Their information will be reviewed to see if they had vaccines for pneumonia or had certain health events, such as pneumonia or lower respiratory tract infection.
The experiences of people that received Prevnar 20 will be compared to the experiences of people that did not receive the vaccine. This will help to show how well Prevnar 20 works at stopping invasive pneumococcal disease, pneumococcal pneumonia, all-cause pneumonia, and lower respiratory tract infection.
Read the detailed description
Community-acquired pneumonia (CAP) is pneumonia acquired outside of a hospital or within the first 48 hours of hospitalization. It is one of the most common reasons for hospitalization in the US, with up to 10% of patients requiring hospitalization and is the leading cause of infectious disease-related death in the US. Streptococcus pneumoniae remains the leading bacterial cause of CAP, although its incidence has declined over time due to vaccination. Streptococcus pneumoniae is also responsible for Invasive Pneumococcal Disease (IPD).
In 2014, the Advisory Committee in Immunization Practices (ACIP) recommended routine use of the 13-valent pneumococcal conjugate vaccine (PCV13) in series with PPSV23 for all adults aged ≥65 years based on the evidence of PCV13's safety and efficacy against PCV13-type IPD and pneumonia in this age group. A higher valency, 20-valent pneumococcal conjugate vaccine (PCV20) builds on the PCV13 vaccine, and includes seven additional serotypes that cause pneumococcal disease. On October 20, 2021, the ACIP recommended that adults ≥65 years, who had not previously received pneumococcal conjugate vaccine or whose previous vaccination history is unknown may receive PCV20 alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with PPSV23. On October 19, 2022, the ACIP updated the previous recommendation, recommending that adults who have previously received PCV13 should receive either a dose of the PCV20 or PPSV23.
As a condition of the accelerated approval for PCV20 in June 2021, Pfizer is currently conducting a post-approval confirmatory study to verify and describe the clinical benefit of PCV20 in adults ≥65 years (NCT05452941). In the interim, this study will evaluate the real-world vaccine effectiveness (VE) of PCV20 against IPD, PP, all-cause pneumonia (ACP), and Lower Respiratory Tract Infection (LRTI) among adults aged ≥65 years in Medicare Fee-for-Service (FFS) Parts A, B, and D.
This structured secondary data collection study is a retrospective cohort study using Medicare FFS claims data to estimate real-world PCV20 VE against IPD, PP, ACP, and LRTI among adults aged ≥65 years in the US.
Study analyses will be conducted at the time-segment level, where PCV20 vaccination is a time-varying exposure. In this time-segment design, individuals who receive a PCV20 vaccine during the patient identification period can contribute up to two time segments during the follow-up period: a PCV20 unvaccinated time segment and a PCV20 vaccinated time segment. Each segment will be attributed to the appropriate vaccination exposure status cohort.
Individuals who do not receive a PCV20 vaccine during the patient identification period can contribute a maximum of 1 time segment to the analysis, which will be attributed to the PCV20 unvaccinated cohort. All analyses will be conducted based on time-segment level data.
For PCV20 unvaccinated time segments, individuals will be followed from their unvaccinated index date until the earliest of the following: 1) PCV20 vaccination, 2) PCV13 vaccination, 3) PPSV23 vaccination, 4) PCV15 vaccination, 5) outcome of interest, 6) disenrollment from Medicare FFS Parts A or B, 7) enrollment in Medicare Part C, 8) death, or 9) end of the study period. For PCV20 vaccinated time segments, individuals will be followed from their PCV20 vaccinated index date until the earliest of the following: 1) PCV13 vaccination, 2) PPSV23 vaccination, 3) PCV15 vaccination, 4) second PCV20 vaccination, 5) outcome of interest, 6) disenrollment from Medicare FFS Parts A or B, 7) enrollment in Medicare Part C, 8) death, or 9) end of the study period.
The primary objective is to estimate overall effectiveness of the PCV20 vaccine against three outcome events - first IPD, PP, and ACP due to any serotype - among adults aged ≥ 65 years.
The secondary objective focuses on estimating the overall VE and absolute difference in incidence of PCV20 against LRTI and subgroup VE and absolute difference in incidence stratified by age groups and risk groups. This will involve comparing the time-to-event for LRTI between the vaccinated and unvaccinated using similar methods as described for the primary outcome.
- Conditions
- Community-Acquired Pneumonia (CAP)
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCV20 Vaccinated | Aged ≥65 years and vaccinated with PCV20 during the study identification period | |
| PCV20 Unvaccinated | Aged ≥65 years and not vaccinated with PCV20 during the study identification period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted PCV20 vaccine effectiveness (VE) against Invasive Pneumococcal Disease (IPD)
Presence of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes (1 inpatient or 1 outpatient in any diagnostic position) representing IPD
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months
Weighted PCV20 VE against Pneumococcal Pneumonia (PP)
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing PP
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or PP up to 24 months
Absolute difference in the incidence of PP by PCV20 vaccination status
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing PP
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or PP up to 24 months
Weighted PCV20 VE against all cause pneumonia (ACP)
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing ACP
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or ACP up to 24 months
Absolute difference in incidence of ACP by PCV20 vaccination status
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing ACP
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or ACP up to 24 months
Absolute difference in the incidence of IPD by PCV20 vaccination status
Presence of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes (1 inpatient or 1 outpatient in any diagnostic position) representing IPD
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months
Secondary outcomes (2)
Weighted PCV20 VE against Lower Respiratory Tract Infection (LRTI)
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing LRTI
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or LRTI up to 24 months
Absolute difference in incidence of LRTI by PCV20 vaccination status
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing LRTI
Measured: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or LRTI up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start20 Jan 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired Pneumonia (CAP)Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 22,234,435 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
- NCT06782282
- Sponsor's protocol ID
- B7471043
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) Among Medicare Fee-for-service Beneficiaries Aged ≥65 Years in the United States
- ClinicalTrials.gov ID
- NCT06782282
- Acronym / sponsor ID
- B7471043
- Conditions
- Community-Acquired Pneumonia (CAP)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,234,435 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 Jan 2025 (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 purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease (a group of severe infections caused by a bacteria called Streptococcus pneumoniae), pneumococcal pneumonia (a bacterial lung disease caused by the germ Streptococcus pneumoniae), all-cause pneumonia (pneumonia caused by any germ including bacteria, a virus, or a fungus), and lower respiratory tract infection (infection of the lower airways in the lung) in people 65 years and older.
This study will use a database of people who have Medicare insurance with names and other identifying information removed. This study will include people who:
- are 65 years and older,
- live in one of the 50 United States or Washington DC, and
- are enrolled in Medicare Fee-for-Service Parts A and B for at least 1 year.
The study uses data that is already being collected and no treatment or vaccine will be given in the study.
People that fit the description above will be followed in the Medicare database for about two years. Their information will be reviewed to see if they had vaccines for pneumonia or had certain health events, such as pneumonia or lower respiratory tract infection.
The experiences of people that received Prevnar 20 will be compared to the experiences of people that did not receive the vaccine. This will help to show how well Prevnar 20 works at stopping invasive pneumococcal disease, pneumococcal pneumonia, all-cause pneumonia, and lower respiratory tract infection.
Detailed description
Community-acquired pneumonia (CAP) is pneumonia acquired outside of a hospital or within the first 48 hours of hospitalization. It is one of the most common reasons for hospitalization in the US, with up to 10% of patients requiring hospitalization and is the leading cause of infectious disease-related death in the US. Streptococcus pneumoniae remains the leading bacterial cause of CAP, although its incidence has declined over time due to vaccination. Streptococcus pneumoniae is also responsible for Invasive Pneumococcal Disease (IPD).
In 2014, the Advisory Committee in Immunization Practices (ACIP) recommended routine use of the 13-valent pneumococcal conjugate vaccine (PCV13) in series with PPSV23 for all adults aged ≥65 years based on the evidence of PCV13's safety and efficacy against PCV13-type IPD and pneumonia in this age group. A higher valency, 20-valent pneumococcal conjugate vaccine (PCV20) builds on the PCV13 vaccine, and includes seven additional serotypes that cause pneumococcal disease. On October 20, 2021, the ACIP recommended that adults ≥65 years, who had not previously received pneumococcal conjugate vaccine or whose previous vaccination history is unknown may receive PCV20 alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with PPSV23. On October 19, 2022, the ACIP updated the previous recommendation, recommending that adults who have previously received PCV13 should receive either a dose of the PCV20 or PPSV23.
As a condition of the accelerated approval for PCV20 in June 2021, Pfizer is currently conducting a post-approval confirmatory study to verify and describe the clinical benefit of PCV20 in adults ≥65 years (NCT05452941). In the interim, this study will evaluate the real-world vaccine effectiveness (VE) of PCV20 against IPD, PP, all-cause pneumonia (ACP), and Lower Respiratory Tract Infection (LRTI) among adults aged ≥65 years in Medicare Fee-for-Service (FFS) Parts A, B, and D.
This structured secondary data collection study is a retrospective cohort study using Medicare FFS claims data to estimate real-world PCV20 VE against IPD, PP, ACP, and LRTI among adults aged ≥65 years in the US.
Study analyses will be conducted at the time-segment level, where PCV20 vaccination is a time-varying exposure. In this time-segment design, individuals who receive a PCV20 vaccine during the patient identification period can contribute up to two time segments during the follow-up period: a PCV20 unvaccinated time segment and a PCV20 vaccinated time segment. Each segment will be attributed to the appropriate vaccination exposure status cohort.
Individuals who do not receive a PCV20 vaccine during the patient identification period can contribute a maximum of 1 time segment to the analysis, which will be attributed to the PCV20 unvaccinated cohort. All analyses will be conducted based on time-segment level data.
For PCV20 unvaccinated time segments, individuals will be followed from their unvaccinated index date until the earliest of the following: 1) PCV20 vaccination, 2) PCV13 vaccination, 3) PPSV23 vaccination, 4) PCV15 vaccination, 5) outcome of interest, 6) disenrollment from Medicare FFS Parts A or B, 7) enrollment in Medicare Part C, 8) death, or 9) end of the study period. For PCV20 vaccinated time segments, individuals will be followed from their PCV20 vaccinated index date until the earliest of the following: 1) PCV13 vaccination, 2) PPSV23 vaccination, 3) PCV15 vaccination, 4) second PCV20 vaccination, 5) outcome of interest, 6) disenrollment from Medicare FFS Parts A or B, 7) enrollment in Medicare Part C, 8) death, or 9) end of the study period.
The primary objective is to estimate overall effectiveness of the PCV20 vaccine against three outcome events - first IPD, PP, and ACP due to any serotype - among adults aged ≥ 65 years.
The secondary objective focuses on estimating the overall VE and absolute difference in incidence of PCV20 against LRTI and subgroup VE and absolute difference in incidence stratified by age groups and risk groups. This will involve comparing the time-to-event for LRTI between the vaccinated and unvaccinated using similar methods as described for the primary outcome.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV20 Vaccinated | – | –Aged ≥65 years and vaccinated with PCV20 during the study identification period |
| PCV20 Unvaccinated | – | –Aged ≥65 years and not vaccinated with PCV20 during the study identification period |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Aged ≥65 years, residing in one of the 50 US states or in Washington, D.C., continuously enrollmed in Medicare FFS Parts A and B for 365 days prior to the index date, allowing for gaps of ≤45 days (baseline period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weighted PCV20 vaccine effectiveness (VE) against Invasive Pneumococcal Disease (IPD)
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months
Presence of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes (1 inpatient or 1 outpatient in any diagnostic position) representing IPD
Weighted PCV20 VE against Pneumococcal Pneumonia (PP)
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or PP up to 24 months
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing PP
Absolute difference in the incidence of PP by PCV20 vaccination status
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or PP up to 24 months
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing PP
Weighted PCV20 VE against all cause pneumonia (ACP)
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or ACP up to 24 months
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing ACP
Absolute difference in incidence of ACP by PCV20 vaccination status
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or ACP up to 24 months
ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing ACP
Absolute difference in the incidence of IPD by PCV20 vaccination status
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months
Presence of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes (1 inpatient or 1 outpatient in any diagnostic position) representing IPD
2 secondary outcomes
Weighted PCV20 VE against Lower Respiratory Tract Infection (LRTI)
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or LRTI up to 24 months
Absolute difference in incidence of LRTI by PCV20 vaccination status
Time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or LRTI up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Community-Acquired Pneumonia (CAP)
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
RecruitingObservational study
Chest Radiography Versus Ultra-Low-Dose Chest Computed Tomography in Adults in the Emergency Department
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Recruiting
Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia
Community-acquired Pneumonia, Community-Acquired Infections
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Pneumonia (CAP), run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Weighted PCV20 vaccine effectiveness (VE) against Invasive Pneumococcal Disease (IPD) (time frame: Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.