Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Community-acquired Pneumonia
In brief
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.
Key facts
- Study ID
- NCT05722938
- Run by
- Biotest
- People needed
- 590
- Starts
- 2023-09-09
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Onze Lieve Vrouw Ziekenhuis — Aalst, Belgium (enrolling)
- AZ Maria Middelares — Ghent, Belgium (enrolling)
- Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
- Sunshine Hospital — Saint Albans, Australia (enrolling)
- Hopital Erasme — Brussels, Belgium (enrolling)
- ZOL — Genk, Belgium (enrolling)
- Estudios Clinicos de los Arroyos — San Nicolás, Argentina (enrolling)
- Sanatorio de la Canada — Villa María, Argentina (enrolling)
- Footscray Hospital — Footscray, Australia (enrolling)
- Austin Health — Heidelberg, Australia (enrolling)
- AZ Sint-Jan — Bruges, Belgium (enrolling)
- Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)
- Antwerp University Hospital (UZA) — Edegem, Belgium (enrolling)
- University of California San Francisco-Fresno — Fresno, California, United States (enrolling)
- Hospital San Roque — Córdoba, Argentina (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (enrolling)
- Sanatorio Parque S.A — Rosario, Santa Fe Province, Argentina (enrolling)
- Sanatorio Guemes — Buenos Aires, Argentina (enrolling)
- Hospital General de Agudos Dr. J. M. Ramos Mejia — Buenos Aires, Argentina (enrolling)
- CEMIC — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
- Lenox Hill Hospital — New York, New York, United States (enrolling)
- Universitair Ziekenhuis Brussel — Jette, Belgium (enrolling)
Full record on ClinicalTrials.gov
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