Status: Recruiting
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 pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.
Participants needed: 590
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: BiotestUpdated: Apr 3, 2026Locations: 147
Eligibility criteria
Written informed consent. [+5]
For an incapacitated subject: any indication that the subject's presumed will wo... [+23]