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New treatment option for Peritonitis
Official title Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
ClinicalTrials.gov ID: NCT03334006
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient is diagnosed with secondary or quaternary peritonitis
- 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...
- Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society).
- SOFA Score ≥ 8
- The concentration of IL-6 is ≥ 1000 pg / ml
You likely can't join if
- Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
- For female patients: The patient is pregnant or breastfeeding.
- The patient is a minor (\< 18 years of age).
- The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²).
- The patient has acute, primarily non-infectious pancreatitis or mediastinitis.
- The patient has a BMI \> 40.
See the full eligibility criteria
- The patient is diagnosed with secondary or quaternary peritonitis
- 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).
- Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society).
- SOFA Score ≥ 8
- The concentration of IL-6 is ≥ 1000 pg / ml
- Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit
- 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
- Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
- For female patients: The patient is pregnant or breastfeeding.
- The patient is a minor (\< 18 years of age).
- The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²).
- The patient has acute, primarily non-infectious pancreatitis or mediastinitis.
- The patient has a BMI \> 40.
- The patient has any contraindication to study drug.
- The patient has participated in another clinical trial within the last 30 days.
- The patient is in a dependent or employment relationship with the sponsor or investigator.
- The patient is institutionalized by court or government order.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Tübingen, Baden-Wurttemberg, Germany
- Regensburg, Bavaria, Germany
- Essen, North Rhine-Westphalia, Germany
- Berlin, State of Berlin, Germany
- Aachen, Germany
- Bochum, Germany
- Dortmund, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Hanover, Germany
- Heidelberg, Germany
- Magdeburg, Germany
- Mainz, Germany
- München, Germany
- Nuremberg, Germany
- Zwickau, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Tübingen, Baden-Wurttemberg, Germany; Regensburg, Bavaria, Germany; Essen, North Rhine-Westphalia, Germany; Berlin, State of Berlin, Germany; Aachen, Germany and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.