Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
ConditionCommunity-acquired Pneumonia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotest
About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent.
Hospitalized, adult (≥ 18 years of age) subject.
Signs of inflammation based on C-reactive protein threshold level.
Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
Disqualifiers
For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
Pregnant or lactating women.
Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
Subjects on ECMO at start of IMP treatment.
Trial design
Treatments tested in this trial
- Trimodulin
- Placebo (human albumin 1%)
Treatment groups
590 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov