Evaluating trimodulin for severe community-acquired pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial aims to assess the efficacy and safety of trimodulin as an adjunctive treatment to standard care in adults hospitalized with severe community-acquired pneumonia who require invasive mechanical ventilation. Participants will be randomly assigned to receive either trimodulin or a placebo for five consecutive days, followed by a follow-up period of up to 90 days. The study will also investigate the pharmacokinetic and pharmacodynamic properties of trimodulin. The trial is designed to be double-blind and multi-center, ensuring robust data collection and analysis.

Why it matters

Who can join: the full rules

Main Inclusion Criteria:

1. Written informed consent.
2. Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age
3. Signs of inflammation based on C-reactive protein threshold level.
4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
5. Radiological (or other imaging technology) evidence consistent with active pneumonia.
6. Acute respiratory failure requiring IMV.

Main Exclusion Criteria:

1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
2. Pregnant or lactating women.
3. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
4. Subjects on ECMO at start of IMP treatment.
5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
6. Subjects discharged from hospital within the previous 14 days.
7. Defined neutrophil counts up to one calendar day prior to start of IMP treatment.
8. Defined platelet counts up to one calendar day prior to start of IMP treatment.
9. Defined hemoglobin within up to one calendar day prior to start of IMP treatment.
10. Pre-existing hemolytic disease.
11. Thromboembolic events (TEEs) caused by other reasons than the current sCAP 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 prior to start of IMP treatment.
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. active tuberculosis, active lung cancer).
15. Pre-existing decompensated heart failure.
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 components of trimodulin / placebo.
18. Selective immunoglobulin A (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.
20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2.
21. Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment.
22. Known treatment with predefined medications, during the last 2 days before start of IMP treatment.
23. Hematopoietic stem cell transplantation 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 trial within 30 days before start of IMP treatment, or previous treatment with IMP in this clinical trial.

Where it's running

• #1007 University of California San Francisco-Fresno
  Fresno, California, United States Recruiting
• # 1021 Northern Westchester Hospital
  Mount Kisco, New York, United States Recruiting
• # 1017 Wake Forest Baptist
  Winston-Salem, North Carolina, United States Recruiting
• # 1022 Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• # 5413 Estudios Clinicos de los Arroyos
  San Nicolás, Buenos, Argentina Recruiting
• # 5415 Sanatorio de la Canada
  Villa María, Córdoba Province, Argentina Recruiting

+120 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Ricard Ferrer Roca, Dr. — Hospital Vall d'Hebron
• Study coordinator: Patrick Langohr
• Email: patrick.langohr@biotest.com
• Phone: +491732947122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.