Trimodulin for Severe Community-Acquired Pneumonia

This study is looking at whether a drug called Trimodulin can help people hospitalized with severe community-acquired pneumonia (sCAP). This is a serious lung infection you get outside of a hospital. The study will compare Trimodulin to a placebo (an inactive substance like human albumin 1%) to see if it's safe and effective when given along with standard care. You might be able to join if you are at least 18 years old (or 12 in the US), have signs of inflammation, and were diagnosed with sCAP recently. The main goal is to see if Trimodulin can lower the death rate within 28 days.

Study design
This is a randomized, placebo-controlled, double-blind study involving about 590 participants across multiple centers. Participants will be randomly assigned to receive either Trimodulin or placebo.
What's involved
You would receive daily IV infusions of the study drug or placebo for 5 consecutive days. There will be follow-up visits or calls until day 29, and potentially longer if you are still hospitalized.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 28 days after treatment, with a final check-in around day 91.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05722938

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Biotest
~590 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:TrimodulinPlacebo (human albumin 1%)

At a glance

Recruiting sites
89 of 154 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
28-day all-cause mortality rate
Measured over Between days 1-29
Community-acquired Pneumonia
154 sites across 37 states
France20
Spain16
Argentina13
Belgium12
Brazil12
Israel8
Philippines8
Hungary6
  • Ricard Ferrer Roca, Dr. · PRINCIPAL_INVESTIGATOR · Hospital Vall d'Hebron

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  • 28-day all-cause mortality rateBetween days 1-29

    Percentage of subjects that died until day 29 regardless of cause of death