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.
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
At a glance
Conditions
Where it's being run
154 sites across 37 statesStudy leadership
- Ricard Ferrer Roca, Dr. · PRINCIPAL_INVESTIGATOR · Hospital Vall d'Hebron
Who to contact
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What this trial measures
- 28-day all-cause mortality rateBetween days 1-29
Percentage of subjects that died until day 29 regardless of cause of death