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

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.

NCT Number	NCT03334006
Lead Sponsor	RWTH Aachen University Collaborators: Biotest
Conditions	Peritonitis, Sepsis, Septic Shock
Enrollment	200 participants
Start Date	2017-11-20
Primary Completion	2027-09 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-11