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A study to test trimodulin in adult hospitalized patients with severe pneumonia
EU CTIS ID: 2022-501352-28-00
What this study is testing
To assess the efficacy of trimodulin based on 28-day all-cause mortality to demonstrate superiority to treatment with placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent obtained from subject or legally acceptable/authorized representative (LAR)
- Hospitalized, adult (≥ 18 years of age) subject (any gender).
- C-reactive protein (CRP) ≥ 70 mg/L up to 1 calendar day prior to start of treatment with IMP.
- 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 must be available from routine SoC.
- Acute respiratory failure requiring IMV, defining sCAP (Appendix 9: sCAP Diagnostic Criteria According to the ATS/IDSA Guideline)
You likely can't join if
- 01. For an incapacitated subject: any indication that the subject’s presumed will would be against inclusion in the trial.
- 18. Selective IgA deficiency with known antibodies to IgA.
- 19. Life expectancy of less than 90 days, according to the investigator’s clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions.
- 02. Pregnant or lactating women.
- 20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI < 16 kg/m2.
- 21. Treatment with > 1 g/kg body weight of polyvalent immunoglobulin preparation in total during the last 21 days before start of IMP treatment
See the full eligibility criteria
Who can join
- Written informed consent obtained from subject or legally acceptable/authorized representative (LAR)
- Hospitalized, adult (≥ 18 years of age) subject (any gender).
- C-reactive protein (CRP) ≥ 70 mg/L up to 1 calendar day prior to start of treatment with IMP.
- 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 must be available from routine SoC.
- Acute respiratory failure requiring IMV, defining sCAP (Appendix 9: sCAP Diagnostic Criteria According to the ATS/IDSA Guideline)
- Treatment with IMP must be started between 1 and 24 hours after initiation of IMV.
- Subject must receive SoC treatment for sCAP according to applicable regional and global sCAP guidelines.
What rules you out
- 01. For an incapacitated subject: any indication that the subject’s presumed will would be against inclusion in the trial.
- 18. Selective IgA deficiency with known antibodies to IgA.
- 19. Life expectancy of less than 90 days, according to the investigator’s clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions.
- 02. Pregnant or lactating women.
- 20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI < 16 kg/m2.
- 21. Treatment with > 1 g/kg body weight of polyvalent immunoglobulin preparation in total during the last 21 days before start of IMP treatment
- 22. Treatment with fluoroquinolone preparations, during the last 2 days before start of IMP treatment
- 23. Hematopoietic stem cell transplantation within 1 year, or previous lung transplantation
- 24. Treatment with investigational medications procedures not according to SoC of the trial site , due to participation in another interventional clinical tria within 30 days before start of IMP treatment or previous IMP treatment with IMP in this clinical trial.
- 25. Employee or direct relative of an employee of the CRO, or the trial site, if employee is directly involved in the trial or otherwise in a dependent relationship with the site staff.
- 26. Persons, subject to legal protection measures, if applicable according to local laws.
- 10. Pre-existing hemolytic disease.
- 03. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
- 04. Subjects on extracorporeal membrane oxygenation (ECMO) at start of IMP treatment.
- 05. Suspected hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP).
- 06. Subjects discharged from hospital within the previous 14 days.
- 07. Severe neutropenia (neutrophil count <500/mm³) per most recent test performed up to 1 calendar day prior to start of IMP treatment.
- 08. Thrombocytopenia (platelet count <30,000/mm³) per most recent test performed up to 1 calendar day prior to start of IMP treatment.
- 09. Hemoglobin (Hb) < 7 g/dL hours per most recent test performed up to 1 calendar day prior to start of IMP treatment.
- 11. Thromboembolic events (TEEs) caused by other reasons than the current sCAP (e.g., cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within 3 months before start of IMP treatment.. unless the risk for further TEEs can be adequately managed with standard prophylaxis or treatment.
- 12. Severe renal impairment, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² per most recent test performed up to 1 calendar day prior to start of IMP treatment (details in Appendix 2: Estimated Glomerular Filtration Rate).*), unless the subject is already on dialysis or continuous replacement therapy.
- 13. End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
- 14. Pre-existing severe lung diseases concomitant to current sCAP (e.g., subjects with active tuberculosis, or active lung cancer).
- 15. Pre-existing decompensated heart failure (New York Heart Association class III–IV).
- 16. Pre-existing severe hepatic cirrhosis, (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.
- 17. Known intolerance to proteins of human origin or known allergic reactions to any of the components of trimodulin / placebo.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United States
- Philippines
- United Kingdom
- Mexico
- South Africa
- Argentina
- Canada
- Israel
- Australia
- New Zealand
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United States; Philippines; United Kingdom; Mexico; South Africa and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.