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

Recruiting Phase 2 Interventional Study
Peritonitis Sepsis Septic Shock
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
RWTH Aachen University · Other
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About This Trial
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 s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The patient is diagnosed with secondary or quaternary peritonitis 2. The time of the surgical infectious source control is within 6 hours of indication (defined as date and time of registration for surgical or minimal invasive procedure). 3. Sepsis and / or septic shock (acco…
Contacts

Center for Translational & Clinical Research (CTC-A)

PEPPER@ukaachen.de

CONTACT