Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID03334006

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin4 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

26 weeks

Total Duration

On this page

Sponsors

R

RWTH Aachen University

Lead Sponsor

B

Biotest

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Pentaglobin4 (IgGAM) as an additional treatment alongside standard care for patients with peritonitis who have undergone surgical infectious source control. This prospective, randomized, controlled trial aims to improve patient outcomes such as survival and organ function, measured by scores like the Multiple Organ Failure (MOF) and Sequential Organ Failure Assessment (SOFA) scores. The study also seeks to identify biomarkers that indicate which patients might benefit most from this personalized therapy. Participants are randomly assigned to receive either standard care alone or standard care plus Pentaglobin4. Pentaglobin4 is given by continuous intravenous infusion over five days, with a dose of 0.4 ml per kg of body weight per hour until a total of 7 ml per kg per day is reached. The control group receives only the standard treatment. The study includes close monitoring of immunological biomarkers and clinical scores to assess treatment effects. During the trial, participants undergo regular assessments including MOF and SOFA scoring to evaluate organ function, as well as survival status at 28 and 90 days. Blood samples are analyzed for biomarkers such as immunoglobulin levels, HLA-DR expression, and NF-kB1. Safety and treatment response are monitored throughout the study period. The main outcome is the change in MOF score from baseline to day 7 after surgery. The total participation time includes the treatment and follow-up assessments up to 90 days.

CONDITIONS

Brief Title

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 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 guidelines
  • SOFA score of 8 or higher
  • IL-6 concentration of at least 1000 pg/ml
  • Antibiotic treatment started within 12 hours of ICU admission
  • Signed informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • Life expectancy less than 90 days due to conditions 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 5 3.4 mg/dl or clearance 4 30 mL/min/1.73 m8)
  • Acute, primarily non-infectious pancreatitis or mediastinitis
  • Body mass index over 40
  • Contraindication to study drug
  • Participation in another clinical trial within the last 30 days
  • Employment or dependent relationship with sponsor or investigator
  • Institutionalized by court or government order

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days

Participants receive Standard-of-Care treatment; those in the intervention group also receive Pentaglobin® by continuous intravenous infusion over 5 days as an add-on therapy.

Daily visits for up to 5 days

Follow-up

Duration - Up to 90 days

Participants are monitored for changes in organ function and survival outcomes following treatment.

Visits on days 5, 7, 28, and 90

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

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Research Team

C

Center for Translational & Clinical Research (CTC-A)

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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Published Research Related To This Trial

Diagnostic value of procalcitonin, interleukin-6, and interleukin-8 in critically ill patients admitted with suspected sepsis.

S Harbarth, K Holeckova, C Froidevaux...

https://pubmed.ncbi.nlm.nih.gov/11500339