Actively Recruiting
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Led by Biotest · Updated on 2026-04-03
590
Participants Needed
147
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Hospitalized adult aged 18 years or older
- Signs of inflammation based on C-reactive protein levels
- Diagnosis of active community-acquired pneumonia before or within 48 hours of hospital admission
- Radiological or imaging evidence consistent with active pneumonia
- Acute respiratory failure requiring invasive mechanical ventilation
You will not qualify if you...
- Incapacitated subjects with presumed will against trial inclusion
- Pregnant or lactating women
- Women of childbearing potential unwilling to use reliable contraception during and for 15 weeks after treatment
- Subjects on extracorporeal membrane oxygenation at treatment start
- Suspected hospital-acquired or ventilator-associated pneumonia
- Hospital discharge within the previous 14 days
- Abnormal neutrophil, platelet, or hemoglobin counts prior to treatment
- Pre-existing hemolytic disease
- Recent thromboembolic events unless adequately managed
- Severe renal impairment or end-stage renal disease
- Pre-existing severe lung diseases like active tuberculosis or lung cancer
- Pre-existing decompensated heart failure
- Severe hepatic cirrhosis or impairment, or hepatocellular carcinoma
- Known intolerance or allergy to human proteins or trial components
- Selective IgA deficiency with antibodies
- Life expectancy under 90 days unrelated to pneumonia
- Morbid obesity (BMI ≥ 40) or malnutrition (BMI < 16)
- Treatment with polyvalent immunoglobulin preparations within 21 days
- Treatment with certain medications within 2 days prior to treatment
- Hematopoietic stem cell or lung transplantation
- Participation in another interventional trial or prior trial treatment within 30 days before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 147 locations
1
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States, 36608
Withdrawn
2
University of California San Francisco-Fresno
Fresno, California, United States, 93701
Actively Recruiting
3
UC Davis Health
Sacramento, California, United States, 95817
Withdrawn
4
Augusta University
Augusta, Georgia, United States, 30912
Withdrawn
5
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
Withdrawn
6
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Withdrawn
7
University of Missouri Clinical Research Center
Columbia, Missouri, United States, 65212
Withdrawn
8
Hannibal Clinic
Hannibal, Missouri, United States, 63401
Withdrawn
9
Mercury Street Medical Group
Butte, Montana, United States, 59701
Withdrawn
10
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
Withdrawn
11
Buffalo VA Medical Center
Buffalo, New York, United States, 14215
Withdrawn
12
Lenox Hill Hospital
New York, New York, United States, 10075-1850
Actively Recruiting
13
Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
14
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Withdrawn
15
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Withdrawn
16
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Withdrawn
17
Medical City Fort Worth
Fort Worth, Texas, United States, 76104
Withdrawn
18
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
19
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
20
Sanatorio Parque S.A. Privado
San Vicente, Córdoba Province, Argentina, 5006
Withdrawn
21
CEMIC
Ciudad Autonoma de Buenos Aire, Argentina, 1431
Actively Recruiting
22
Sanatorio de la Trinidad Mitre
Ciudad Autonoma de Buenos Aire, Argentina, C1039AAO
Withdrawn
23
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Argentina, C1181ACH
Withdrawn
24
Hospital General de Agudos Dr. Ignacio Pirovano
Ciudad Autonoma de Buenos Aire, Argentina, C1430BKC
Withdrawn
25
Clinica Adventista Belgrano
Ciudad Autonoma de Buenos Aire, Argentina, C1430EGF
Withdrawn
26
Clinica Chutro
Córdoba, Argentina, 5000
Withdrawn
27
Hospital San Roque
Córdoba, Argentina, 5000
Actively Recruiting
28
Sanatorio Privado de la Canada - Cordoba
Córdoba, Argentina, X5000BSQ
Withdrawn
29
Centro Medico IPAM
Rosario, Argentina, S2001SBK
Withdrawn
30
Estudios Clinicos de los Arroyos
San Nicolás, Argentina, 2900
Actively Recruiting
31
Sanatorio de la Canada
Villa María, Argentina, 5900
Actively Recruiting
32
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Withdrawn
33
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
34
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
35
Footscray Hospital
Footscray, Australia, 3011
Actively Recruiting
36
Austin Health
Heidelberg, Australia, 3084
Actively Recruiting
37
Sunshine Hospital
Saint Albans, Australia, 3021
Actively Recruiting
38
KABEG-Klinikum Klagenfurt
Klagenfurt, Austria, 9020
Withdrawn
39
AKH - Medizinische Universität Wien
Vienna, Austria, 1090
Withdrawn
40
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
Actively Recruiting
41
AZ Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
42
Hopital Erasme
Brussels, Belgium, 1070
Actively Recruiting
43
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
44
Antwerp University Hospital (UZA)
Edegem, Belgium, 2650
Actively Recruiting
45
ZOL
Genk, Belgium, 3600
Actively Recruiting
46
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
47
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090
Actively Recruiting
48
C. H. R. de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
49
CHU Charleroi Hôpital Civil Marie Curie
Lodelinsart, Belgium, 6042
Actively Recruiting
50
Clinique Saint-Pierre
Ottignies, Belgium, 1340
Actively Recruiting
51
AZ Delta VZW
Roeselare, Belgium, 8800
Actively Recruiting
52
UPECLIN - Unidade de Pesquisa Clínica
Botucatu, Brazil, 18618-686
Actively Recruiting
53
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas, Brazil, 13060-904
Withdrawn
54
Hospital do Rocio
Campo Largo, Brazil, 83606-177
Actively Recruiting
55
Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos
Caxias do Sul, Brazil, 95070-560
Actively Recruiting
56
Hospital de Clínicas de Passo Fundo
Passo Fundo, Brazil, 99010-260
Actively Recruiting
57
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90020-090
Actively Recruiting
58
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Withdrawn
59
Hospital Ernesto Dornelles
Porto Alegre, Brazil, 90160-093
Actively Recruiting
60
CIP - Centro Integrado de Pesquisa
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
61
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, 01323-020
Withdrawn
62
Universidade Municipal de Sao Caetano do Sul (USCS)
São Paulo, Brazil, 09530-700
Withdrawn
63
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 65691
Actively Recruiting
64
Oblastni nemocnice Kolin a.s.
Kolín, Czechia, 28002
Actively Recruiting
65
Hospital Kyjov
Kyjov, Czechia, 69701
Actively Recruiting
66
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
67
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Actively Recruiting
68
Hôpital Louis Mourier
Colombes, France, 92700
Withdrawn
69
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, France, 38043
Actively Recruiting
70
CHRU Lille - Hôpital Salengro
Lille, France, 59037
Withdrawn
71
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87000
Withdrawn
72
Centre Hospitalier de Melun
Melun, France, 77000
Actively Recruiting
73
CHU Nice-Hopital de l' Archet
Nice, France, 06202
Actively Recruiting
74
CHU Nice Hopital Pasteur 2
Nice, France, 6100
Actively Recruiting
75
Hôpital Bichat - Claude Bernard
Paris, France, 75018
Actively Recruiting
76
Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
Paris, France, 75020
Actively Recruiting
77
Hôpital Tenon
Paris, France, 75020
Actively Recruiting
78
Hôpital Cochin
Paris, France, 75679
Actively Recruiting
79
CHU Reims - Hôpital Robert Debré
Reims, France, 51100
Actively Recruiting
80
CHU Rennes - Hôpital Pontchaillou
Rennes, France, 35000
Actively Recruiting
81
CHU Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
82
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Actively Recruiting
83
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, France, 67098
Withdrawn
84
Hôpital Sainte Musse
Toulon, France, 83056
Withdrawn
85
CHU Tours - Hôpital Bretonneau
Tours, France, 37000
Withdrawn
86
Hôpital Nord Franche-Comté
Trévenans, France, 90400
Actively Recruiting
87
Charité Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, Germany, 10117
Withdrawn
88
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
89
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
90
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Withdrawn
91
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Withdrawn
92
Bugat Pal Korhaz
Gyöngyös, Hungary, 3200
Withdrawn
93
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, Hungary, 5700
Withdrawn
94
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, Hungary, 2143
Withdrawn
95
Aneszteziologiai es Intenziv Terapias Intezet
Pécs, Hungary, 7624
Withdrawn
96
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 6725
Withdrawn
97
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary, 8000
Actively Recruiting
98
St James's Hospital
Dublin, Ireland, D08NYH1
Actively Recruiting
99
Beaumont Hospital
Dublin, Ireland, D09 V2N0
Actively Recruiting
100
St Vincents University Hospital
Dublin, Ireland, Dublin 4
Actively Recruiting
101
University Hospital Galway
Galway, Ireland, H91YR71
Actively Recruiting
102
Soroka Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
103
Bnai Zion Medical Center
Haifa, Israel, 31048
Actively Recruiting
104
Rambam Medical Center
Haifa, Israel, 31096
Actively Recruiting
105
The Lady Davis Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
106
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
107
Kaplan Medical Center
Rehovot, Israel, 761001
Actively Recruiting
108
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
109
Middlemore Hospital
Otahuhu, New Zealand, 2025
Actively Recruiting
110
Capital, Coast and Hutt Valley District - Wellington Regional Hospital
Wellington, New Zealand, 6021
Actively Recruiting
111
Baguio General Hospital and Medical Center
Baguio City, Philippines, 2600
Actively Recruiting
112
Dr. Jose N. Rodriguez Memorial Hospital
Caloocan, Philippines, 1427
Actively Recruiting
113
Davao Doctors Hospital
Davao City, Philippines, 8000
Withdrawn
114
Southern Philippines Medical Center
Davao City, Philippines, 8000
Actively Recruiting
115
St.Paul's Hospital
Iloilo City, Philippines, 5000
Withdrawn
116
West Visayas State University Medical Center
Iloilo City, Philippines, 5000
Actively Recruiting
117
Philippine General Hospital
Manila, Philippines, 1000
Actively Recruiting
118
Lung Center of the Philippines
Quezon City, Philippines, 1100
Actively Recruiting
119
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Withdrawn
120
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania, 050098
Actively Recruiting
121
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
Timișoara, Romania, 300723
Actively Recruiting
122
Johese Clinical Research
Centurion, Gauteng, South Africa, 0157
Actively Recruiting
123
Emmed Clinical Research
Pretoria, Gauteng, South Africa, 0002
Withdrawn
124
Into Research
Pretoria, Gauteng, South Africa, 0181
Withdrawn
125
Worthwhile Clinical Trials
Johannesburg, South Africa, 1500
Withdrawn
126
RYEXO Clinical Research Zuid Afrikaans Hospital
Pretoria, South Africa, 0002
Withdrawn
127
RYEXO Clinical Research
Pretoria, South Africa, 0184
Terminated
128
Dr JM Engelbrecht Trial Site
Somerset West, South Africa, 7130
Actively Recruiting
129
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
130
Hospital de la Santa Creu i de Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
131
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 8035
Actively Recruiting
132
Hospital Universitari de Bellvitge
Barcelona, Spain, 8907
Actively Recruiting
133
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
134
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Actively Recruiting
135
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
136
Hospital Universitario La Paz
Madrid, Spain, 28046
Withdrawn
137
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Withdrawn
138
Hospital Universitario Son Espases
Palma de Mallorca, Spain, 07120
Actively Recruiting
139
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
140
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43007
Actively Recruiting
141
Hospital Universitari Mutua de Terrassa
Terrassa, Spain, 8221
Actively Recruiting
142
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Withdrawn
143
Queen Elizabeth University Campus
Glasgow, United Kingdom, G11 6NT
Actively Recruiting
144
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Withdrawn
145
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Actively Recruiting
146
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
147
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
P
Patrick Langohr
CONTACT
C
Claudia Schulte
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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