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

This study is for adults, aged 18 or over, who are in hospital with a severe lung infection (community-acquired pneumonia). You would need to have signs of inflammation from blood tests and imaging scans (like X-rays) that confirm the pneumonia. Crucially, you must need a breathing machine (ventilator) to help you breathe due to the severity of your lung infection.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have certain other serious health conditions, especially problems with your kidneys, liver, or heart that are already very severe. If you had a previous hospital stay very recently, or if your lung infection was caught in hospital rather than out in the community, you wouldn't be able to take part. Researchers also need to make sure you don't have certain blood conditions or are using specific medical equipment like ECMO.

If you are eligible and agree to take part, you will receive either Trimodulin or a dummy medicine called a placebo. You'll get this medicine once a day for five days in a row, in addition to the usual care you receive in hospital. After these five days, doctors will closely watch your progress for about three to four weeks.

There will be follow-up calls or visits up to day 29, and possibly a final check-up around day 91 if you're still doing well. If you are still in hospital at day 29, your care will be followed up until you are discharged or up to day 90. Throughout the study, you'll have various check-ups and tests, which might include blood tests and physical examinations, to see how you're responding to the treatment and to monitor your general health. The total time for follow-up could be up to 90 days.