Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (s… (NCT05722938) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
United States590 participantsStarted 2023-09-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Radiological (or other imaging technology) evidence consistent with active pneumonia.
✓. Acute respiratory failure requiring IMV.
Exclusion criteria
✕. 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.
✕. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
✕. Subjects discharged from hospital within the previous 14 days.
✕. Defined neutrophil counts up to one calendar day prior to start of IMP treatment.