Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (s… (NCT05722938) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
United States, Argentina, Australia590 participantsStarted 2023-09-09
Plain-language summary
The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV).
Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent.
. Hospitalized, adult (≥ 18 years of age) subject.
. Signs of inflammation based on C-reactive protein threshold level.
. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
. Radiological (or other imaging technology) evidence consistent with active pneumonia.
. Acute respiratory failure requiring IMV.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
. Pregnant or lactating women.
. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
. Subjects on ECMO at start of IMP treatment.
. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
. Subjects discharged from hospital within the previous 14 days.
. Defined neutrophil counts up to one calendar day prior to start of IMP treatment.
. Defined platelet counts up to one calendar day prior to start of IMP treatment.