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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 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.

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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.

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

FieldValue
Enrollment Target 590 participants
Start Date 2023-09-09
Est. Completion 2028-07-31
Phase Phase 3

Sponsor

Biotest

3 total trials

What the Registry Record Tells You About NCT05722938

The ClinicalTrials.gov registry entry for NCT05722938 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 590 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109,056-participant average among 9 other Community-acquired Pneumonia trials with a reported enrollment target (99% lower). The listed sponsor is Biotest, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.