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 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
This trial does not accept healthy volunteersQualifiers
Written informed consent.
Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age
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
Design model
Parallel
Treatments tested in this trial
Trimodulin
DrugIMP will be administered via IV infusion on 5 consecutive days
Placebo (human albumin 1%)
DrugIMP will be administered via IV infusion on 5 consecutive days
Treatment groups
590 Participants
are divided into 2 treatment groupsGroup A: TrimodulinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
28-day all-cause mortality rate
Percentage of subjects that died until day 29 regardless of cause of death
Time frame
Between days 1-29Secondary outcomes
1
90-day all-cause mortality rate
Percentage of subjects that died until day 91 regardless of cause of death
Time frame
Between days 1-912
Deterioration rate (up to day 29)
Percentage of subjects with at least one deterioration event up to day 29
Time frame
Up to day 293
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7
Change in Sequential Organ Failure Assessment (SOFA)
Time frame
Between baseline and Day 74
Proportion of subjects with clinical cure of pneumonia up to day 29
Percentage of subjects with clinical cure of pneumonia
Time frame
Up to day 29Other outcomes
1
Serum concentration of immunoglobulins
Changes of serum concentration of IgM, IgA, and IgG from baseline, during and after treatment
Time frame
Day 1, 5, 142
Pharmacokinetic assessment of immunoglobulins
Assessment of changes in serum concentrations (g/L) of IgM, IgA, and IgG before, during and after treatment
Time frame
Day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 293
Pharmacodynamic assessment of disease related serum proteins
Assessment of relative changes in serum concentrations from baseline, during and after treatment of factors and markers of coagulation (e.g. % change in D-dimer), markers of inflammation (e.g. % change in CRP), complement factors (e.g. % change in C3, C4), specific antibody titers against sCAP-related pathogens (e.g. % change in Streptococcus pneumoniae antibody titers)
Time frame
Day 1, 2, 3, 4, 5, 7, 14, 21, 29 Source ClinicalTrials.gov