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Personalized treatment with Pentaglobin® for patients with peritonitis after surgery

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

PHASE2 · RWTH Aachen University · NCT03334006

This study is testing if adding Pentaglobin® to standard care can help patients recover better from peritonitis after surgery.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorRWTH Aachen University (other)
Locations20 sites (Vienna and 19 other locations)
Trial IDNCT03334006 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Pentaglobin® as an adjuvant treatment for patients suffering from peritonitis following surgical intervention. It is a prospective, randomized, controlled trial that compares the outcomes of patients receiving standard care with those receiving additional Pentaglobin® treatment. The study will assess improvements in patient outcomes using various scoring systems, including Multiple Organ Failure (MOF) and SOFA scores, and will identify biomarkers to determine which patient subpopulations benefit most from this personalized therapy. The ultimate goal is to lay the groundwork for a future Phase III trial based on the findings of this study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with secondary or quaternary peritonitis who are experiencing sepsis or septic shock and meet specific clinical criteria.

Not a fit: Patients with a life expectancy of less than 90 days due to unrelated medical conditions or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with peritonitis, potentially reducing mortality and organ failure rates.

How similar studies have performed: Other studies have shown promise in using personalized medicine approaches for treating sepsis and related conditions, but the specific use of Pentaglobin® in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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 (according to the current sepsis guideline of the German Sepsis Society).
4. SOFA Score ≥ 8
5. The concentration of IL-6 is ≥ 1000 pg / ml
6. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit
7. The informed consent form has been signed by the patient and / or by his legal representative (such as his spouse, an health care proxy authorized or a legal representative) or by a consultant physician

Exclusion criteria

1. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
2. For female patients: The patient is pregnant or breastfeeding.
3. The patient is a minor (\< 18 years of age).
4. The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²).
5. The patient has acute, primarily non-infectious pancreatitis or mediastinitis.
6. The patient has a BMI \> 40.
7. The patient has any contraindication to study drug.
8. The patient has participated in another clinical trial within the last 30 days.
9. The patient is in a dependent or employment relationship with the sponsor or investigator.
10. The patient is institutionalized by court or government order.

Where this trial is running

Vienna and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Peritonitis, Sepsis, Septic Shock, Pentaglobin®, Personalized Medicine

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.