Overview

Personalised Medicine With IgGAM Compared With Standard of Care for Treatment of Peritonitis After Infectious Source Control (the PEPPER Trial)

Status:
Suspended

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to test the adjuvant Immuneglobulins G, A and M (IgGAM) treatment for: 1. An improvement of the outcome for the patient's peritonitis. This will be investigated by using scores such as the multiple organ failure (MOF) and Sequential Organ Failure Assessment (SOFA) scores as well as survival data. 2. Identification of biomarkers [Ig level, procalcitonin (PCT), interleukin-6 (IL 6), Human Leukocyte Antigen - antigen D Related (HLA DR), nuclear factor kappa-light-chain-enhancer of activated B cells (NF kB1), adrenomedullin (ADM), pathogen spectrum], to identify patient subpopulations that profit most from treatment with IgGAM. Such patients will comprise the basis for a further study, which will be a randomised, controlled, double-blind trial (RCT) to demonstrate the value of this treatment. 3. Furthermore, these biomarkers are expected to help with developing a "personalised" adjuvant therapy with IgGAM in the indication of peritonitis.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

RWTH Aachen University

Collaborator:

Biotest

Treatments:

Immunoglobulin A
Immunoglobulin M

Criteria

Inclusion Criteria:

1. Peritonitis

2. The time of the surgical infectious source control must have been within 6 h after the
indication (defined as the time of the registration of the surgical procedure/ minimal
invasive surgery)

3. Sepsis and septic shock (according to the current Sepsis Guideline)

4. SOFA Score ≥ 8

5. IL-6 ≥ 1000 pg / ml

6. Start of therapy with antibiotics and IgGAM (Pentaglobin) within 12 hours after
admission to the ICU

7. Signed informed consent by the patient himself or by his legal representative, such as
a court-appointed supervisor or by an authorized proxy authorized representative or by
a consultant

Exclusion criteria

1. Patients with a life expectancy of less than 90 days due to medical conditions that
are not associated with postoperative peritonitis or with sepsis / septic shock

2. Pregnant, breastfeeding women

3. Minors (< 18 years)

4. Patients with a known dialysis-requiring chronic renal function (creatinine ≥ 3.4 mg /
dl or creatinine clearance ≤ 30 mL / min / 1.73 m2)

5. Patients with acute, primary non-infectious pancreatitis or mediastinitis

6. BMI> 40

7. Patients with a contraindication to study medication

8. Participate in another medication study within the last 30 days

9. Persons who are in a relationship of dependency or employment relationship with the
sponsor or auditor

10. Persons who are placed in an institution on a judicial or administrative order