Last updated on January 2020

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


Brief description of study

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.

Detailed Study Description

The purpose of this study is to test the adjuvant 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 and SOFA scores as well as survival data.
  2. Identification of biomarkers (Ig level, PCT, IL 6, HLA DR, Nf kB1, 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.

The control group will receive standard-of-care treatment, i.e., the IgGAM is an add-on treatment in this study.

The active study treatment is IgGAM (Pentaglobin). IgGAM is administered by continuous infusion over 5 days at a dose level of 0.4 ml per kg body weight per hour, until a total dose of 7 ml/kg on that day has been reached; administration will then be stopped and recommenced on the following day, until administration has been completed for 5 consecutive days.

Primary target variable The relative number of patients whose MOF score improves by 0.8 points on Day 7 (i.e., percentage of 'responders'). The primary analysis will be performed with the per protocol population (see below).

The MOF score is determined in the morning, with the following scoring for each organ (lungs, heart, kidneys, liver, blood): normal function, 0; dysfunction, 1; individual organ failure, 2. An aggregate score greater than 4 implies multi-organ failure. Patients who die will be assigned the maximum score of 10 and will be included in the population assessment.

Secondary target variables

  • Overall 28-day survival,
  • Overall 90-day survival,
  • MOF score on Day 5,
  • Relative number of patients with MOF (i.e., > 4 MOF points) on Day 7. Additional study variables
  • Time course of the biomarkers (PCT, IL 6, HLA DR, ADM, Immuneglobulins M, G, A), the SOFA score, the Mannheim Peritonitis Index, the surrogate variables for organ dysfunction and survival according to Heyland et al. 2011 and vital signs.
  • Influence of the biomarkers NF kB1, ADM and pathogen spectrum upon the outcome for the patient.
  • Comparison of the MOF score with other scores, such as the SOFA score, for assessment of organ dysfunction.

Clinical Study Identifier: NCT03334006

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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