Biotest
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.
This is a randomized, placebo-controlled, double-blind, multi-center, multi-national, phase III trial, to assess the efficacy and safety of trimodulin compared to placebo treatment, as adjunctive treatment to SoC in hospitalized subjects with sCAP receiving IMV. Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center. Investigational medicinal product (IMP) treatments will be blinded. Subject will be administered IMP once daily on 5 consecutive days (day 1 through day 5) adjunctive to SoC. The subsequent follow-up phase comprises maximally 23 days (d…
Main Inclusion Criteria: 1. Written informed consent. 2. Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age 3. Signs of inflammation based on C-reactive protein threshold level. 4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission. 5. Radiological (or other imaging technology) evidence consistent with active pneumonia. 6. Acute respiratory failure requiring IMV. Main Exclusion Criteria: 1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in th…
IMP will be administered via IV infusion on 5 consecutive days
IMP will be administered via IV infusion on 5 consecutive days