ESsCAPE
Research type
Research Study
Full title
A randomized , placebo-controlled, double blind, multi -center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community acquired pneumonia (sCAP)
IRAS ID
1007042
Contact name
Iris Bobenhausen
Contact email
Sponsor organisation
Biotest AG
Clinicaltrials.gov Identifier
Research summary
This ESsCAPE study is a randomised, double-blind, multi-centre, phase III trial that will evaluate the safety and efficacy of trimodulin compared to placebo as an additional therapy to standard of care treatments for adult patients with severe community acquired pneumonia (sCAP), who are hospitalised and require ventilation to breathe. sCAP is a life-threatening disease, as patients may suffer from complications such as sepsis and multiple organ failure. As this represents an unmet need for these patients the primary goal is to improve patient’s outcomes and the quality of life with trimodulin.
Trimodulin is an immunoglobulin preparation which contains antibodies directed against a wide range of infectious pathogens. The hope is that trimodulin will augment the standard of care therapies, strengthening the body’s immune responses to prevent further worsening of the disease and ultimately reduce the symptoms of sCAP, allowing patients to recover from the disease.
Trimodulin will be compared with a placebo and administered intravenously. Study participants will be randomised by chance, by a computer on a 1:1 basis to receive trimodulin or placebo in addition to the standard of care treatment and medication usually given in this indication. This means participants will have an equal chance of receiving either trimodulin or placebo. Exposure to placebo is deemed necessary to allow reliable evaluation of the beneficial effect of trimodulin, as well as of the adverse events observed with trimodulin and compared with those observed with the inactive placebo.
The study will run in 4 phases: Screening (up to 2 days), Treatment period (5 days), Follow-Up Period (up to 24 days) and Extended Follow-Up period (up to 72 days).
Study duration for each participant will be approximately 103 days (15 weeks). The Sponsor of this study is Biotest AG.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0119
Date of REC Opinion
12 Jan 2024
REC opinion
Further Information Favourable Opinion