Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients

Phase 1

• Conditions: Investigation of Pentaglobin® therapy in patients with sepsis and/or septic shock triggered by peritonitis after surgical infectious source control and simultaneous administration of antibiotics.; MedDRA version: 21.1Level: LLTClassification code 10081559Term: Septic peritonitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-001788-34-AT
• Lead Sponsor: niversity Hospital Aachen, AöR, Dean of the Medical Faculty of the RWTH Aachen for the Managing Board of the University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. the patient has a diagnosis of secondary or quaternary peritonitis.
2. the time of source control is within 6 h of the indication (defined as the date and time of registration for surgery or minimally invasive procedure).
3. sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.
4. the SOFA score is = 8.
5. the concentration of IL-6 is = 1000 pg/ml.
6. antibiotic therapy is started within 12 h after admission to the intensive care unit.
7. the informed consent form has been signed by the patient himself and/or his legal representative (such as his spouse, a proxy with effective power of attorney for health care or a court-appointed guardian) or by a consultant.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.
2. for female patients only: There is a pregnancy or the patient is breastfeeding.
3. the patient is a minor (<18 years).
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 BMI is > 40.
7. the patient has a contraindication to the study medication.
8. patient has participated in another drug study within the last 30 days.
9. the patient has a dependent or employment relationship with the sponsor or investigator.
10. the patient is institutionalised by court or regulatory order.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified