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Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
NCT05722938 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05722938
The ClinicalTrials.gov registry entry for NCT05722938 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 590 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biotest, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05722938 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Michigan, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05722938?
The interventions under investigation include: Trimodulin (DRUG), Placebo (human albumin 1%) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05722938?
This trial is sponsored by Biotest, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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