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Evaluating trimodulin for severe community-acquired pneumonia

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)

Phase 3 Interventional Biotest · NCT05722938

This study is testing if adding trimodulin to standard treatment can help adults with severe pneumonia who need breathing support feel better and recover faster.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment590 (estimated)
Ages18 Years and up
SexAll
SponsorBiotest Industry-sponsored
Locations147 sites (Mobile, Alabama and 146 other locations)
Trial IDNCT05722938 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 18 and older with active severe community-acquired pneumonia and acute respiratory failure requiring invasive mechanical ventilation.

Not a fit: Patients with suspected hospital-acquired pneumonia or those on ECMO are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with severe community-acquired pneumonia requiring mechanical ventilation.

How similar studies have performed: Other studies have shown promise with similar adjunctive treatments for pneumonia, but the specific use of trimodulin in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion Criteria:

1. Written informed consent.
2. Hospitalized, adult (≥ 18 years of age) subject.
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 this trial is running

Mobile, Alabama and 146 other locations

+97 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Community-acquired PneumoniaSevere Community-acquired Pneumonia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.