NCT03334006 Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
| NCT ID | NCT03334006 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | RWTH Aachen University |
| Condition | Peritonitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2017-11-20 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2017-11-20 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 (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.
Contact & Investigator
Center for Translational & Clinical Research (CTC-A)
✉ PEPPER@ukaachen.deGernot Marx, Univ.-Prof.
PRINCIPAL INVESTIGATOR
RWTH Aachen University
Frequently Asked Questions
Who can join the NCT03334006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritonitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03334006 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03334006 currently recruiting?
Yes, NCT03334006 is actively recruiting participants. Contact the research team at PEPPER@ukaachen.de for enrollment information.
Where is the NCT03334006 trial being conducted?
This trial is being conducted at Vienna, Austria, Tübingen, Germany, Regensburg, Germany, Essen, Germany and 11 additional locations.
Who is sponsoring the NCT03334006 clinical trial?
NCT03334006 is sponsored by RWTH Aachen University. The principal investigator is Gernot Marx, Univ.-Prof. at RWTH Aachen University. The trial plans to enroll 200 participants.