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Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

NCT05722938

RecruitingPhase 3

Sponsor: Biotest

Conditions: Community-acquired Pneumonia

Interventions: Trimodulin, Placebo (human albumin 1%)

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Czechia, France

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 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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (154)
  • Mobile, Alabama, United States
  • Fresno, California, United States
  • Sacramento, California, United States
  • Augusta, Georgia, United States
  • Lansing, Michigan, United States
  • Royal Oak, Michigan, United States
  • Columbia, Missouri, United States
  • Hannibal, Missouri, United States
  • Butte, Montana, United States
  • Newark, New Jersey, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Winston-Salem, North Carolina, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • San Vicente, Córdoba Province, Argentina
  • Rosario, Santa Fe Province, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Córdoba, Argentina
  • Córdoba, Argentina
  • + 124 more on CT.gov