NCT03334006: PEPPER

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

Recruiting now Phase 2 Last updated 9 September 2025

What this trial tests

Phase 2 trial testing Pentaglobin®/Standard of Care in Peritonitis in 200 participants. Currently enrolling.

Timeline

20 November 2017

Primary endpoint
1 September 2027

1 March 2028

Quick facts

Lead sponsor	RWTH Aachen University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	20 November 2017
Primary completion	1 September 2027
Estimated completion	1 March 2028
Sites	20 locations across Austria, Germany

Drugs / interventions tested

• Pentaglobin®/Standard of Care — full drug profile →

Conditions studied

• Peritonitis — all drugs for Peritonitis →
• Sepsis — all drugs for Sepsis →
• Septic Shock — all drugs for Septic Shock →

Sponsor

RWTH Aachen University

Who can join

18 and older, any sex, with Peritonitis or Sepsis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis.
  Time frame: 7 days
  The MOF score is determined in the morning. The following points are distributed per organ: Normal organ function: 0 points; organ dysfunction: 1 point; single organ failure: 2 points. A score \> 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score are assigned a score of 10 points.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the host response in sepsis: current approaches and future evidence.
   Bode C, Weis S, Sauer A, Wendel-Garcia P, et al · · 2023 · cited 56× · PMID 38057824 · DOI 10.1186/s13054-023-04762-6
2. Immune therapy in sepsis: Are we ready to try again?
   Davies R, O'Dea K, Gordon A. · · 2018 · cited 52× · PMID 30515242 · DOI 10.1177/1751143718765407
3. Towards personalized medicine: a scoping review of immunotherapy in sepsis.
   Slim MA, van Mourik N, Bakkerus L, Fuller K, et al · · 2024 · cited 38× · PMID 38807151 · DOI 10.1186/s13054-024-04964-6
4. Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial.
   Kalvelage C, Zacharowski K, Bauhofer A, Gockel U, et al · · 2019 · cited 13× · PMID 30832742 · DOI 10.1186/s13063-019-3244-4