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Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Sponsor: Biotest
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
No
Conditions
Interventions
Trimodulin
IMP will be administered via IV infusion on 5 consecutive days
Placebo (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