Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05722938

PHASE3

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

Sponsor: Biotest

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

590

Start Date

2023-09-09

Completion Date

2028-07-31

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Community-acquired Pneumonia

Interventions

DRUG

Trimodulin

IMP will be administered via IV infusion on 5 consecutive days

DRUG

Placebo (human albumin 1%)

IMP will be administered via IV infusion on 5 consecutive days

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.

Locations (147)

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, United States

University of California San Francisco-Fresno

Fresno, California, United States

UC Davis Health

Sacramento, California, United States

Augusta University

Augusta, Georgia, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

University of Missouri Clinical Research Center

Columbia, Missouri, United States

Hannibal Clinic

Hannibal, Missouri, United States

Mercury Street Medical Group

Butte, Montana, United States

St. Michael's Medical Center

Newark, New Jersey, United States

Buffalo VA Medical Center

Buffalo, New York, United States

Lenox Hill Hospital

New York, New York, United States

Wake Forest Baptist

Winston-Salem, North Carolina, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Medical City Fort Worth

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Sanatorio Parque S.A. Privado

San Vicente, Córdoba Province, Argentina

CEMIC