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

Testing Trimodulin for safety in severe pneumonia patients.

Recruiting
18 years and older
All
Phase 3

This study tests a medicine called **Trimodulin** for adults with severe **community-acquired pneumonia (sCAP)** who are on a breathing machine (**invasive mechanical ventilation (IMV)**). Trimodulin is given along with usual hospital care to see if it helps more than a fake treatment (**placebo**). The study is **randomized** (participants are chosen by chance to get either Trimodulin or placebo) and **double-blind** (neither the participants nor the doctors know who gets the real treatment). Participants will get the treatment once a day for 5 days, followed by up to 28 days of follow-up checks.

To join, you must be an adult, already in the hospital, and have sCAP. Certain health conditions, like severe heart or lung disease, or being pregnant, might mean you can't participate. The study will check how Trimodulin moves through the body (**pharmacokinetics**) and its effects (**pharmacodynamics**).

  • The study lasts up to 90 days, including follow-ups.
  • Participants receive daily treatments for 5 days.
  • There are specific health criteria for joining the study.
Study details
    Community-acquired Pneumonia

NCT05722938

Biotest

10 May 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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