RecruitingPhase 3NCT05722938

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

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)

Sponsor

Biotest

Enrollment

590 participants

Start Date

Sep 9, 2023

Study Type

INTERVENTIONAL

Conditions

Community-acquired Pneumonia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo (human albumin 1%) and a drug called Trimodulin for people with community-acquired pneumonia. The study is currently recruiting participants at 147 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

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Interventions

DRUGTrimodulin

IMP will be administered via IV infusion on 5 consecutive days

DRUGPlacebo (human albumin 1%)

IMP will be administered via IV infusion on 5 consecutive days

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

# 3304 Hôpital Tenon

Paris, France

# 3316 Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon

Paris, France

# 4909 Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

# 4903 Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

# 4910 Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

# 4904 Charité Universitätsmedizin Berlin - Campus Charité Mitte

Berlin, Germany

# 4905 Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

# 3606 Bugat Pal Korhaz

Gyöngyös, Hungary

# 3607 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, Hungary

# 3608 Pest Megyei Flor Ferenc Korhaz

Kistarcsa, Hungary

# 3610 Aneszteziologiai es Intenziv Terapias Intezet

Pécs, Hungary

# 3612 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary

# 3604 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

# 3501 St James's Hospital

Dublin, Ireland

# 3503 Beaumont Hospital

Dublin, Ireland

# 3504 St Vincents University Hospital

Dublin, Ireland

# 3502 University Hospital Galway

Galway, Ireland

# 9704 Soroka Medical Center

Beersheba, Israel

# 9701 Bnai Zion Medical Center

Haifa, Israel

# 9703 Rambam Medical Center

Haifa, Israel

# 9706 The Lady Davis Carmel Medical Center

Haifa, Israel

# 9702 Rabin Medical Center

Petah Tikva, Israel

# 9705 Kaplan Medical Center

Rehovot, Israel

# 9708 Shamir Medical Center (Assaf Harofe)

Rishon LeZiyyon, Israel

# 9707 Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

# 6401 Middlemore Hospital

Otahuhu, New Zealand

# 6403 Capital, Coast and Hutt Valley District - Wellington Regional Hospital

Wellington, New Zealand

# 6302 Baguio General Hospital and Medical Center

Baguio City, Philippines

# 6307 Dr. Jose N. Rodriguez Memorial Hospital

Caloocan, Philippines

# 6304 Southern Philippines Medical Center

Davao City, Philippines

# 6309 Davao Doctors Hospital

Davao City, Philippines

# 6301 West Visayas State University Medical Center

Iloilo City, Philippines

# 6306 St.Paul's Hospital

Iloilo City, Philippines

# 6308 Philippine General Hospital

Manila, Philippines

# 6303 Lung Center of the Philippines

Quezon City, Philippines

# 4001 Institutul Clinic Fundeni

Bucharest, Romania

# 4003 Spitalul Universitar de Urgenta Bucuresti

Bucharest, Romania

# 4002 Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

Timișoara, Romania

# 2706 Johese Clinical Research

Centurion, Gauteng, South Africa

# 2707 Emmed Clinical Research

Pretoria, Gauteng, South Africa

# 2708 Into Research

Pretoria, Gauteng, South Africa

# 2701 Dr JM Engelbrecht Trial Site

Somerset West, Western Cape, South Africa

# 2703 Worthwhile Clinical Trials

Johannesburg, South Africa

# 2704 RYEXO Clinical Research Zuid Afrikaans Hospital

Pretoria, South Africa

# 2705 RYEXO Clinical Research

Pretoria, South Africa

# 3409 Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

# 3423 Hospital Universitari Parc Tauli

Sabadell, Barcelona, Spain

# 3419 Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, Spain

# 3405 Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain

# 3410 Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

# 3418 Clinica Universidad de Navarra

Pamplona, Navarre, Spain

# 3420 Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

# 3414 Hospital del Mar

Barcelona, Spain

# 3408 Hospital Clinic de Barcelona

Barcelona, Spain

# 3421 Hospital Clinic de Barcelona

Barcelona, Spain

# 3406 Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain

# 3407 Hospital Universitari Vall d'Hebrón

Barcelona, Spain

# 3417 Hospital Universitari de Bellvitge

Barcelona, Spain

# 3411 Hospital Universitari de Girona Dr Josep Trueta

Girona, Spain

# 3413 Hospital Universitario Clinico San Carlos

Madrid, Spain

# 3415 Hospital Universitario La Paz

Madrid, Spain

# 3422 Hospital Universitario Virgen del Rocio

Seville, Spain

# 3404 Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

# 3416 Hospital Universitari i Politecnic La Fe

Valencia, Spain

# 4405 Derriford Hospital

Plymouth, Devon, United Kingdom

# 4401 St Thomas' Hospital

London, Greater London, United Kingdom

# 4410 King's College Hospital

London, Greater London, United Kingdom

# 4403 Queen Elizabeth University Campus

Glasgow, Strathclyde, United Kingdom

# 4404 Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

# 4411 University Hospital of Wales

Cardiff, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05722938

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