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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 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 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

2026-09-14

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; 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 (170)

#1012 Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, United States

# 1033 Banner University Medical Center

Phoenix, Arizona, United States

#1007 University of California San Francisco-Fresno

Fresno, California, United States

# 1015 UC Davis Health

Sacramento, California, United States

# 1002 Augusta University

Augusta, Georgia, United States

# 1028 University of Maryland, Baltimore

Baltimore, Maryland, United States

# 1034 Brigham and Women's Hospital

Boston, Massachusetts, United States

# 1010 Sparrow Clinical Research Institute Site 1010

Lansing, Michigan, United States

# 1003 William Beaumont Hospital

Royal Oak, Michigan, United States

#1009 University of Missouri Clinical Research Center

Columbia, Missouri, United States

# 1006 Hannibal Clinic

Hannibal, Missouri, United States

# 1005 Mercury Street Medical Group

Butte, Montana, United States

# 1001 St. Michael's Medical Center

Newark, New Jersey, United States

# 1011 Buffalo VA Medical Center

Buffalo, New York, United States

# 1021 Northern Westchester Hospital

Mount Kisco, New York, United States

# 1030 NYU Langone Medical Center (Tisch Hospital)

New York, New York, United States

# 1031 Health Hospitals Bellvue

New York, New York, United States

# 1023 Mount Sinai Hospital

New York, New York, United States

# 1032 NYC Langone Brooklyn

New York, New York, United States

# 1017 Wake Forest Baptist

Winston-Salem, North Carolina, United States

# 1025 University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

# 1004 Ohio State University Wexner Medical Center

Columbus, Ohio, United States

# 1013 University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

# 1016 Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

# 1018 Vanderbilt University Medical Cente

Nashville, Tennessee, United States

# 1020 Medical City Fort Worth

Fort Worth, Texas, United States

# 1022 Houston Methodist Hospital

Houston, Texas, United States

# 1022 Houston Methodist Hospital

Houston, Texas, United States

# 1026 Intermountain Medical Center

Murray, Utah, United States

# 1019 University of Utah

Salt Lake City, Utah, United States

# 5404 Sanatorio de la Trinidad Mitre

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

# 5413 Estudios Clinicos de los Arroyos

San Nicolás, Buenos, Argentina

# 5409 Hospital San Roque

Córdoba, Córdoba Province, Argentina

# 5412 Clinica Chutro

Córdoba, Córdoba Province, Argentina

# 5416 Sanatorio Privado de la Canada - Cordoba

Córdoba, Córdoba Province, Argentina

# 5405 Sanatorio Parque S.A. Privado

San Vicente, Córdoba Province, Argentina

# 5415 Sanatorio de la Canada

Villa María, Córdoba Province, Argentina

# 5420 Sanatorio Parque S.A.

Rosario, Santa Fe Province, Argentina

# 5411 Centro Medico IPAM

Rosario, Santa Fe Province, Argentina

# 5414 Cemic

Buenos Aires, Argentina

# 5406 Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

# 5418 Sanatorio Guemes Site 5418

Buenos Aires, Argentina

# 5419 Hospital General de Agudos Dr. J. M. Ramos Mejia

Buenos Aires, Argentina

# 5417 Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

# 5408 Hospital General de Agudos Dr. Ignacio Pirovano

Buenos Aires, Argentina

# 5407 Clinica Adventista Belgrano

Buenos Aires, Argentina

# 6102 Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

# 6105 Monash Medical Centre

Clayton, Victoria, Australia

# 6104 Footscray Hospital

Footscray, Victoria, Australia

# 6101 Austin Health

Heidelberg, Victoria, Australia

# 6103 Sunshine Hospital

Saint Albans, Victoria, Australia

# 6106 Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

# 4302 KABEG-Klinikum Klagenfurt

Klagenfurt, Austria

# 4301 AKH - Medizinische Universität Wien

Vienna, Austria

# 3212 Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

# 3207 AZ Sint-Jan

Bruges, Belgium

# 3205 HUB Erasme

Brussels, Belgium

# 3203 Cliniques Universitaires Saint-Luc

Brussels, Belgium

# 3206 Antwerp University Hospital (UZA)

Edegem, Belgium

# 3211 Zol

Genk, Belgium

# 3210 AZ Maria Middelares

Ghent, Belgium

# 3204 Universitair Ziekenhuis Brussel

Jette, Belgium

# 3209 C. H. R. de la Citadelle

Liège, Belgium

# 3208 CHU Charleroi Hôpital Civil Marie Curie

Lodelinsart, Belgium

# 3201 Clinique Saint-Pierre

Ottignies, Belgium

# 3213 AZ Delta VZW

Roeselare, Belgium

# 5516 Hospital do Rocio

Campo Largo, Paraná, Brazil

# 5510 Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos

Caxias do Sul, Rio Grande, Brazil

# 5518 Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande, Brazil

# 5503 Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande, Brazil

# 5507 Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande, Brazil

# 5509 Hospital Ernesto Dornelles

Porto Alegre, Rio Grande, Brazil

# 5519 Hospital Moinhos de Vento

Porto Alegre, Rio Grande, Brazil

# 5512 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, São Paulo, Brazil

# 5508 HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

Campinas, São Paulo, Brazil

# 5514 Universidade Municipal de Sao Caetano do Sul (USCS)

São Caetano do Sul, São Paulo, Brazil

# 5513 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

# 5517 Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

#4202 Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

# 4203 Oblastni nemocnice Kolin a.s.

Kolín, Czechia

# 4204 Hospital Kyjov

Kyjov, Czechia

#4201 Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

# 3317 CHU Nice-Hopital de l' Archet

Nice, Alpes Maritime, France

# 3320 CHU Nice Hopital Pasteur 2

Nice, Alpes Maritime, France

# 3321 CHU Reims - Hôpital Robert Debré

Reims, Ardennes, France

# 3306 CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, Bas Rhin, France

# 3308 CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Bas Rhin, France

# 3310 Hôpital Louis Mourier

Colombes, Haute de Seine, France

# 3311 CHU de Limoges - Hôpital Dupuytren

Limoges, Haute Vienne, France

# 3319 CHU Rennes - Hôpital Pontchaillou

Rennes, Ille Et Vilaine, France

# 3314 CHU Tours - Hôpital Bretonneau

Tours, Indre Et Loire, France

# 3318 CHU de Grenoble - Hôpital Albert Michallon

Grenoble, Isere, France

# 3315 CHRU Lille - Hôpital Salengro

Lille, Landes, France

# 3305 CHU Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

# 3303 Centre Hospitalier de Melun

Melun, Seine Maritime, France

# 3302 Hôpital Nord Franche-Comté

Trévenans, Territoire De Belfort, France

# 3309 Centre Hospitalier Victor Dupouy

Argenteuil, Val d'Oise, France

# 3313 Hôpital Sainte Musse

Toulon, Var, France

# 3312 Hôpital Cochin

Paris, France

# 3301 Hôpital Bichat - Claude Bernard

Paris, France

And 70 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (170)