Actively Recruiting
Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
Led by RWTH Aachen University · Updated on 2025-09-15
200
Participants Needed
20
Research Sites
536 weeks
Total Duration
On this page
Sponsors
R
RWTH Aachen University
Lead Sponsor
B
Biotest
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to 1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival. 2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, NF-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment. 3. In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.
CONDITIONS
Official Title
Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with secondary or quaternary peritonitis
- Surgical infectious source control performed within 6 hours of indication
- Diagnosis of sepsis and/or septic shock according to current German Sepsis Society guidelines
- SOFA score of 8 or higher
- Interleukin-6 (IL-6) concentration of 1000 pg/ml or higher
- Antibiotic treatment started within 12 hours of admission to the intensive care unit
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Life expectancy less than 90 days due to causes unrelated to peritonitis or sepsis
- Female patients who are pregnant or breastfeeding
- Patients under 18 years of age
- Known chronic renal dysfunction requiring dialysis (creatinine 3.4 mg/dl or creatinine clearance 30 mL/min/1.73 m8)
- Acute, primarily non-infectious pancreatitis or mediastinitis
- Body mass index (BMI) over 40
- Any contraindication to the study drug
- Participation in another clinical trial within the last 30 days
- Dependent or employment relationship with the sponsor or investigator
- Institutionalized by court or government order
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Trial Site Locations
Total: 20 locations
1
Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
Vienna, Austria, 1090
Actively Recruiting
2
Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
3
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, Germany, 93053
Active, Not Recruiting
4
Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
5
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin
Berlin, State of Berlin, Germany, 12203
Actively Recruiting
6
Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care
Aachen, Germany, 52074
Actively Recruiting
7
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Bochum, Germany, 44892
Actively Recruiting
8
Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
Dortmund, Germany, 44309
Terminated
9
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
Dresden, Germany, 01307
Withdrawn
10
Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie
Düsseldorf, Germany, 40225
Withdrawn
11
Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Frankfurt, Germany, 60590
Actively Recruiting
12
Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
13
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
Hamburg, Germany, 20246
Actively Recruiting
14
Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin
Hanover, Germany, 30625
Withdrawn
15
Universitätsklinikum Heidelberg, Anästhesiologische Klinik
Heidelberg, Germany, 69120
Withdrawn
16
Klinikum Magdeburg, Klinik für Intensivmedizin
Magdeburg, Germany, 39130
Withdrawn
17
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Mainz, Germany, 55131
Withdrawn
18
Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
München, Germany, 81377
Actively Recruiting
19
Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin
Nuremberg, Germany, 90419
Actively Recruiting
20
Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Zwickau, Germany, 08060
Actively Recruiting
Research Team
C
Center for Translational & Clinical Research (CTC-A)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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