🏛️ Verified NIH Record • Updated 2026-07-23

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) (NCT05722938)

A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Hospitalized Subjects With Severe Community-acquired Pneumonia (sCAP)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Biotest

🩺 Plain-English Summary (8th-Grade Level)

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 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.

Who can join: Review the eligibility criteria below.

Location: Pulmonary Associates of Mobile, P.C. — Mobile, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (154 Sites)

Showing the first 25 of 154 sites.

  • Pulmonary Associates of Mobile, P.C. — Mobile, Alabama
  • University of California San Francisco-Fresno — Fresno, California
  • UC Davis Health — Sacramento, California
  • Augusta University — Augusta, Georgia
  • Sparrow Clinical Research Institute — Lansing, Michigan
  • William Beaumont Hospital — Royal Oak, Michigan
  • University of Missouri Clinical Research Center — Columbia, Missouri
  • Hannibal Clinic — Hannibal, Missouri
  • Mercury Street Medical Group — Butte, Montana
  • St. Michael's Medical Center — Newark, New Jersey
  • Buffalo VA Medical Center — Buffalo, New York
  • Lenox Hill Hospital — New York, New York
  • Wake Forest Baptist — Winston-Salem, North Carolina
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
  • Jefferson University Hospitals — Philadelphia, Pennsylvania
  • Vanderbilt University Medical Center — Nashville, Tennessee
  • Medical City Fort Worth — Fort Worth, Texas
  • Houston Methodist Hospital — Houston, Texas
  • University of Utah — Salt Lake City, Utah
  • Sanatorio Parque S.A. Privado — San Vicente, Córdoba Province
  • Sanatorio Parque S.A — Rosario, Santa Fe Province
  • Sanatorio Guemes — Buenos Aires,
  • Hospital General de Agudos Dr. J. M. Ramos Mejia — Buenos Aires,
  • CEMIC — Ciudad Autonoma de Buenos Aire,
  • Sanatorio de la Trinidad Mitre — Ciudad Autonoma de Buenos Aire,

📞 Contact the Study Coordinator

Phone: +491732947122

Email: patrick.langohr@biotest.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗