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NCT05722938 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
A Phase 3 study of Community-acquired Pneumonia, sponsored by Biotest.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 590
- Enrollment target
- 20
- Study locations
NCT05722938: Recruiting Phase 3 study of Community-acquired Pneumonia, sponsored by Biotest.
NCT05722938 is a Phase 3 study of Community-acquired Pneumonia that is actively recruiting participants, run by Biotest. The registered enrollment target is 590 participants, below the 109,056-participant average among 9 other Community-acquired Pneumonia trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05722938, a Phase 3 study of Community-acquired Pneumonia, is actively recruiting participants, sponsored by Biotest.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 590 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.
Primary Outcome
Percentage of subjects that died until day 29 regardless of cause of death
Conditions Studied
Interventions
- DRUG Trimodulin
- DRUG Placebo (human albumin 1%)
Study Locations (20)
California
- University of California San Francisco-Fresno - Fresno
- UC Davis Health - Sacramento
Michigan
- Sparrow Clinical Research Institute - Lansing
- William Beaumont Hospital - Royal Oak
Missouri
- University of Missouri Clinical Research Center - Columbia
- Hannibal Clinic - Hannibal
New York
- Buffalo VA Medical Center - Buffalo
- Lenox Hill Hospital - New York
Texas
- Medical City Fort Worth - Fort Worth
- Houston Methodist Hospital - Houston
Alabama
- Pulmonary Associates of Mobile, P.C. - Mobile
Georgia
- Augusta University - Augusta
Montana
- Mercury Street Medical Group - Butte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 590 participants |
| Start Date | 2023-09-09 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 3 |
What NCT05722938 shows while recruiting
NCT05722938 is an interventional study that assigns participants to a tested intervention. The registered 590 participants enrollment target is mid-sized for trials with a published cap, below the 109,056-participant average among 9 other Community-acquired Pneumonia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Community-acquired Pneumonia appearing as the primary indexed condition, and to 2 interventions - of which Trimodulin is the first listed.
NCT05722938 names 20 study sites across 15 states, led by California, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT05722938 about?
NCT05722938 is a clinical study titled "Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)". The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokin...
What is the current status of trial NCT05722938?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 590 participants. The study started on 2023-09-09. Estimated completion is 2028-07-31.
What conditions does trial NCT05722938 study?
This clinical trial studies the following conditions: Community-acquired Pneumonia.
What interventions are being tested in trial NCT05722938?
The interventions under investigation include: Trimodulin (DRUG), Placebo (human albumin 1%) (DRUG).
Who is sponsoring clinical trial NCT05722938?
This trial is sponsored by Biotest, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05722938 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Community-acquired Pneumonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05722938's enrollment target sits among peer trials
590 8th of 9 higher than 2 of 9 other Community-acquired Pneumonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Community-acquired Pneumonia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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