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

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

Details

• Lead Sponsor: RWTH Aachen University
• Collaborator: Biotest
• Treatments: Immunoglobulin A; Immunoglobulin M