Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
NCT ID: NCT03334006
Last Updated: 2025-09-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-11-20
Study Completion Date
2028-03-31
Brief Summary
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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.
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.
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Detailed Description
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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.
The control group receives Standard-of-Care treatment. The intervention group is additionally treated with IgGAM (Pentaglobin®) as an add-on treatment to Standard-of-Care.
Pentaglobin® is administered by continuous intravenous infusion over a period of 5 days of 0.4 ml/kg body weight/hour until the total dose of 7 ml/kg body weight/day is reached.
Primary outcome: Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis.
The MOF score is determined in the morning. The following score points are distributed per organ: Normal organ function: 0 score points; organ dysfunction: 1 score point; single organ failure: 2 score points. A score \> 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score was obtained are assigned a score of 10 score points.
Secondary outcome:
* Death within 28 days
* Death within 90 days
* Change in MOF score from baseline to day 5
* Multi-Organ Failure ( \> 4 MOF score points on day 7)
Exploratory objectives:
* Effects of Pentaglobin® therapy on the SOFA score (determined in the organs lung, CNS, circulation, liver, coagulation and kidney).
* Interaction of the biomarkers "NF-kB1" (steady), "CRP (≥ 70 mg/L), IgA (\< 150 mg/dl), IgG (\< 700 mg/dl), IgM (\< 35 mg/dl) and HLA-DR expression (≤ 8,000 molecules per monocyte) with therapy in terms of change in MOF score from baseline to days 5 and 7 and death within 28 and 90 days.
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.
The control group receives Standard-of-Care treatment. The intervention group is additionally treated with IgGAM (Pentaglobin®) as an add-on treatment to Standard-of-Care.
Pentaglobin® is administered by continuous intravenous infusion over a period of 5 days of 0.4 ml/kg body weight/hour until the total dose of 7 ml/kg body weight/day is reached.
Primary outcome: Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis.
The MOF score is determined in the morning. The following score points are distributed per organ: Normal organ function: 0 score points; organ dysfunction: 1 score point; single organ failure: 2 score points. A score \> 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score was obtained are assigned a score of 10 score points.
Secondary outcome:
* Death within 28 days
* Death within 90 days
* Change in MOF score from baseline to day 5
* Multi-Organ Failure ( \> 4 MOF score points on day 7)
Exploratory objectives:
* Effects of Pentaglobin® therapy on the SOFA score (determined in the organs lung, CNS, circulation, liver, coagulation and kidney).
* Interaction of the biomarkers "NF-kB1" (steady), "CRP (≥ 70 mg/L), IgA (\< 150 mg/dl), IgG (\< 700 mg/dl), IgM (\< 35 mg/dl) and HLA-DR expression (≤ 8,000 molecules per monocyte) with therapy in terms of change in MOF score from baseline to days 5 and 7 and death within 28 and 90 days.
Conditions
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Peritonitis
Sepsis
Septic Shock
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The control group receives a Standard-of-Care treatment. The intervention group is additionally treated with IgGAM (Pentaglobin®) as an add-on treatment to Standard-of-Care.
The preparation to be provided contains (per ml solution) 50 mg human plasma proteins, of which ≥ 95 % are immunoglobulins: IgM 6 mg, IgA 6 mg and IgG 38 mg. The IgG subclass distribution is IgG1 \~ 63 %, IgG2 \~ 26 %, IgG3 \~ 4 %, IgG4 \~ 7 %.
Pentaglobin® is administered by continuous intravenous infusion over a period of 5 day of 0.4 ml/kg body weight/hour until the total dose of 7 ml/kg body weight/day is reached.
The preparation to be provided contains (per ml solution) 50 mg human plasma proteins, of which ≥ 95 % are immunoglobulins: IgM 6 mg, IgA 6 mg and IgG 38 mg. The IgG subclass distribution is IgG1 \~ 63 %, IgG2 \~ 26 %, IgG3 \~ 4 %, IgG4 \~ 7 %.
Pentaglobin® is administered by continuous intravenous infusion over a period of 5 day of 0.4 ml/kg body weight/hour until the total dose of 7 ml/kg body weight/day is reached.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Control arm
Standard of Care treatment
Group Type
NO_INTERVENTION
No interventions assigned to this group
Verum arm
Standard of Care treatment + Pentaglobin®
Group Type
ACTIVE_COMPARATOR
Pentaglobin®/Standard of Care
Intervention Type
DRUG
Standard-of-Care treatment + Pentaglobin®
Interventions
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Pentaglobin®/Standard of Care
Standard-of-Care treatment + Pentaglobin®
Intervention Type
DRUG
Eligibility Criteria
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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
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Biotest
INDUSTRY
Sponsor Role
collaborator
RWTH Aachen University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gernot Marx, Univ.-Prof.
Role: PRINCIPAL_INVESTIGATOR
RWTH Aachen University
Locations
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Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
Vienna, , Austria
Site Status
RECRUITING
Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, Baden-Wurttemberg, Germany
Site Status
RECRUITING
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, Germany
Site Status
ACTIVE_NOT_RECRUITING
Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin
Essen, North Rhine-Westphalia, Germany
Site Status
RECRUITING
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin
Berlin, State of Berlin, Germany
Site Status
RECRUITING
Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care
Aachen, , Germany
Site Status
RECRUITING
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Bochum, , Germany
Site Status
RECRUITING
Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
Dortmund, , Germany
Site Status
TERMINATED
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
Dresden, , Germany
Site Status
WITHDRAWN
Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie
Düsseldorf, , Germany
Site Status
WITHDRAWN
Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Frankfurt, , Germany
Site Status
RECRUITING
Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie
Freiburg im Breisgau, , Germany
Site Status
RECRUITING
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
Hamburg, , Germany
Site Status
RECRUITING
Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin
Hanover, , Germany
Site Status
WITHDRAWN
Universitätsklinikum Heidelberg, Anästhesiologische Klinik
Heidelberg, , Germany
Site Status
WITHDRAWN
Klinikum Magdeburg, Klinik für Intensivmedizin
Magdeburg, , Germany
Site Status
WITHDRAWN
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Mainz, , Germany
Site Status
WITHDRAWN
Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
München, , Germany
Site Status
RECRUITING
Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin
Nuremberg, , Germany
Site Status
RECRUITING
Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Zwickau, , Germany
Site Status
RECRUITING
Countries
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Austria
Germany
Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
References
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Reference Type
BACKGROUND
Wong PF, Gilliam AD, Kumar S, Shenfine J, O'Dair GN, Leaper DJ. Antibiotic regimens for secondary peritonitis of gastrointestinal origin in adults. Cochrane Database Syst Rev. 2005 Apr 18;2005(2):CD004539. doi: 10.1002/14651858.CD004539.pub2.
Reference Type
BACKGROUND
Mebazaa A, Laterre PF, Russell JA, Bergmann A, Gattinoni L, Gayat E, Harhay MO, Hartmann O, Hein F, Kjolbye AL, Legrand M, Lewis RJ, Marshall JC, Marx G, Radermacher P, Schroedter M, Scigalla P, Stough WG, Struck J, Van den Berghe G, Yilmaz MB, Angus DC. Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure. J Intensive Care. 2016 Mar 31;4:24. doi: 10.1186/s40560-016-0151-6. eCollection 2016.
Reference Type
BACKGROUND
Kalvelage C, Zacharowski K, Bauhofer A, Gockel U, Adamzik M, Nierhaus A, Kujath P, Eckmann C, Pletz MW, Bracht H, Simon TP, Winkler M, Kindgen-Milles D, Albertsmeier M, Weigand M, Ellger B, Ragaller M, Ullrich R, Marx G. Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial. Trials. 2019 Mar 4;20(1):156. doi: 10.1186/s13063-019-3244-4.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513526-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
2016-001788-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15-167
Identifier Type: -
Identifier Source: org_study_id
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