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)
Status: Recruiting
Location: See all (130) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Written informed consent.
• Hospitalized, adult (≥ 18 years of age) subject.
• Signs of inflammation based on C-reactive protein threshold level.
• Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
• Radiological (or other imaging technology) evidence consistent with active pneumonia.
• Acute respiratory failure requiring IMV.
Locations
United States
Alabama
Pulmonary Associates of Mobile, P.C.
RECRUITING
Mobile
California
University of California San Francisco-Fresno
RECRUITING
Fresno
UC Davis Health
RECRUITING
Sacramento
Georgia
Augusta University
RECRUITING
Augusta
Michigan
Sparrow Clinical Research Institute
RECRUITING
Lansing
William Beaumont Hospital
WITHDRAWN
Royal Oak
Missouri
University of Missouri Clinical Research Center
WITHDRAWN
Columbia
Hannibal Clinic
WITHDRAWN
Hannibal
Montana
Mercury Street Medical Group
WITHDRAWN
Butte
North Carolina
Wake Forest Baptist
RECRUITING
Winston-salem
New Jersey
St. Michael's Medical Center
RECRUITING
Newark
New York
Buffalo VA Medical Center
WITHDRAWN
Buffalo
Lenox Hill Hospital
RECRUITING
New York
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Jefferson University Hospitals
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Medical City Fort Worth
RECRUITING
Fort Worth
Houston Methodist Hospital
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Other Locations
Argentina
CEMIC
RECRUITING
Ciudad Autonoma De Buenos Aire
Clinica Adventista Belgrano
RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital General de Agudos Dr. Ignacio Pirovano
RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital Italiano de Buenos Aires
RECRUITING
Ciudad Autonoma De Buenos Aire
Sanatorio de la Trinidad Mitre
RECRUITING
Ciudad Autonoma De Buenos Aire
Clinica Chutro
RECRUITING
Córdoba
Hospital San Roque
RECRUITING
Córdoba
Sanatorio Privado de la Canada - Cordoba
WITHDRAWN
Córdoba
Centro Medico IPAM
RECRUITING
Rosario
Estudios Clinicos de los Arroyos
RECRUITING
San Nicolás
Sanatorio Parque S.A. Privado
WITHDRAWN
San Vicente
Sanatorio de la Canada
RECRUITING
Villa María
Australia
Monash Medical Centre
RECRUITING
Clayton
Footscray Hospital
RECRUITING
Footscray
Austin Health
RECRUITING
Heidelberg
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Sunshine Hospital
RECRUITING
Saint Albans
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
KABEG-Klinikum Klagenfurt
RECRUITING
Klagenfurt
AKH - Medizinische Universität Wien
RECRUITING
Vienna
Belgium
AZ Sint-Jan
RECRUITING
Bruges
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Hopital Erasme
RECRUITING
Brussels
Antwerp University Hospital (UZA)
RECRUITING
Edegem
AZ Maria Middelares
RECRUITING
Ghent
Universitair Ziekenhuis Brussel
RECRUITING
Jette
C. H. R. de la Citadelle
RECRUITING
Liège
CHU Charleroi Hôpital Civil Marie Curie
RECRUITING
Lodelinsart
Clinique Saint-Pierre
RECRUITING
Ottignies
Brazil
UPECLIN - Unidade de Pesquisa Clínica
RECRUITING
Botucatu
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
WITHDRAWN
Campinas
Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos
RECRUITING
Caxias Do Sul
Hospital de Clínicas de Passo Fundo
RECRUITING
Passo Fundo
Hospital de Clínicas de Porto Alegre
WITHDRAWN
Porto Alegre
Hospital Ernesto Dornelles
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
CIP - Centro Integrado de Pesquisa
RECRUITING
São José Do Rio Preto
Hospital Alemão Oswaldo Cruz
RECRUITING
São Paulo
Universidade Municipal de Sao Caetano do Sul (USCS)
RECRUITING
São Paulo
France
Centre Hospitalier Victor Dupouy
RECRUITING
Argenteuil
Hôpital Louis Mourier
WITHDRAWN
Colombes
CHU de Grenoble - Hôpital Albert Michallon
RECRUITING
Grenoble
CHRU Lille - Hôpital Salengro
WITHDRAWN
Lille
CHU de Limoges - Hôpital Dupuytren
WITHDRAWN
Limoges
Centre Hospitalier de Melun
RECRUITING
Melun
CHU Nice Hopital Pasteur 2
RECRUITING
Nice
CHU Nice-Hopital de l' Archet
RECRUITING
Nice
Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
RECRUITING
Paris
Hôpital Bichat - Claude Bernard
RECRUITING
Paris
Hôpital Cochin
RECRUITING
Paris
Hôpital Tenon
RECRUITING
Paris
CHU Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
CHU Saint-Etienne
RECRUITING
Saint-etienne
CHU Strasbourg - Hôpital Hautepierre
WITHDRAWN
Strasbourg
CHU Strasbourg - Nouvel Hôpital Civil
RECRUITING
Strasbourg
Hôpital Sainte Musse
WITHDRAWN
Toulon
CHU Tours - Hôpital Bretonneau
WITHDRAWN
Tours
Hôpital Nord Franche-Comté
RECRUITING
Trévenans
Germany
Charité Universitätsmedizin Berlin - Campus Charité Mitte
RECRUITING
Berlin
Universitätsklinikum Hamburg-Eppendorf
WITHDRAWN
Hamburg
Medizinische Hochschule Hannover
WITHDRAWN
Hanover
Hungary
Bugat Pal Korhaz
WITHDRAWN
Gyöngyös
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
RECRUITING
Gyula
Pest Megyei Flor Ferenc Korhaz
RECRUITING
Kistarcsa
Aneszteziologiai es Intenziv Terapias Intezet
RECRUITING
Pécs
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING
Szeged
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
RECRUITING
Székesfehérvár
Ireland
Beaumont Hospital
RECRUITING
Dublin
St James's Hospital
RECRUITING
Dublin
St Vincents University Hospital
RECRUITING
Dublin
Israel
Soroka Medical Center
RECRUITING
Beersheba
Bnai Zion Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
The Lady Davis Carmel Medical Center
RECRUITING
Haifa
Rabin Medical Center
RECRUITING
Petah Tikva
Kaplan Medical Center
RECRUITING
Rehovot
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
New Zealand
Middlemore Hospital
RECRUITING
Otahuhu
Philippines
Baguio General Hospital and Medical Center
RECRUITING
Baguio City
Dr. Jose N. Rodriguez Memorial Hospital
RECRUITING
Caloocan
Davao Doctors Hospital
RECRUITING
Davao City
Southern Philippines Medical Center
RECRUITING
Davao City
St.Paul's Hospital
RECRUITING
Iloilo City
West Visayas State University Medical Center
RECRUITING
Iloilo City
Philippine General Hospital
RECRUITING
Manila
Lung Center of the Philippines
RECRUITING
Quezon City
Romania
Institutul Clinic Fundeni
WITHDRAWN
Bucharest
Spitalul Universitar de Urgenta Bucuresti
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Pius Brinzeu
RECRUITING
Timișoara
South Africa
Johese Clinical Research
RECRUITING
Centurion
Worthwhile Clinical Trials
RECRUITING
Johannesburg
Emmed Clinical Research
RECRUITING
Pretoria
Into Research
RECRUITING
Pretoria
RYEXO Clinical Research
RECRUITING
Pretoria
RYEXO Clinical Research Zuid Afrikaans Hospital
WITHDRAWN
Pretoria
Dr JM Engelbrecht Trial Site
RECRUITING
Somerset West
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i de Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebrón
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitari de Girona Dr Josep Trueta
RECRUITING
Girona
Hospital Universitario Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
WITHDRAWN
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitari de Tarragona Joan XXIII
RECRUITING
Tarragona
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
United Kingdom
Queen Elizabeth University Campus
RECRUITING
Glasgow
Royal Surrey County Hospital
RECRUITING
Guildford
St Thomas' Hospital
RECRUITING
London
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
Iris Bobenhausen, PhD
iris.bobenhausen@biotest.com
+4915222801073
Backup
Claudia Schulte
claudia.schulte@biotest.com
+4915222801491
Time Frame
Start Date: 2023-09-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 590
Treatments
Experimental: Trimodulin
Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.
Placebo_comparator: Placebo
Human albumin 1%
Related Therapeutic Areas
Sponsors
Leads: Biotest