PeritonitisPhase 2PEPPERNCT03334006
Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
A Phase 2 study of Peritonitis and Sepsis, run by RWTH Aachen University at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis, Sepsis, Septic Shock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 20 Nov 2017to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Center for Translational & Clinical Research (CTC-A) contact
20 sites in 2 countries
Germany19 sites, 11 recruiting
- Recruiting
Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care
Aachen, 52074
OPintensivmedizin@ukaachen.de
Gernot Marx, Univ.-Prof. Dr. med.
- Recruiting
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin
Berlin, State of Berlin, 12203
stefan.angermair@charite.de
Stefan Angermair, Dr. med.
- Recruiting
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Bochum, 44892
anaesthesie@kk-bochum.de
Michael Adamzik, Univ. - Prof. Dr. med.
- Terminated
Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
Dortmund, 44309
- Withdrawn
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
Dresden, 01307
- Withdrawn
Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie
Düsseldorf, 40225
- Recruiting
Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin
Essen, North Rhine-Westphalia, 45147
pepper@uk-essen.de
Thorsten Brenner, Univ.-Prof. Dr. med.
- Recruiting
Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Frankfurt, 60590
direktion.anaesthesie@kgu.de
Kai Zacharowski, Univ.-Prof. Dr. med.
- Recruiting
Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie
Freiburg im Breisgau, 79106
info@uniklinik-freiburg.de
Stefan Utzolino, Prof. Dr. med.
- Recruiting
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
Hamburg, 20246
anaesthesiologie@uke.de
Axel Nierhaus, Dr. med.
- Withdrawn
Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin
Hanover, 30625
- Withdrawn
Universitätsklinikum Heidelberg, Anästhesiologische Klinik
Heidelberg, 69120
- Withdrawn
Klinikum Magdeburg, Klinik für Intensivmedizin
Magdeburg, 39130
- Withdrawn
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Mainz, 55131
- Recruiting
Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
München, 81377
Direktion_AVT-Klinik@med.uni-muenchen.de
Markus Albertsmeier, PD Dr. med.
- Recruiting
Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin
Nuremberg, 90419
sekretariat_anaes_kkn@klinikum-nuernberg.de
Jens Kubitz, Univ.-Prof. Dr.
- Recruiting
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, 93053
alexander.leibold@ukr.de
Alexander Dejaco, Dr. med.
- Terminated
Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Zwickau, 08060
kains@hbk-zwickau.de
Udo Gottschaldt, Dr. med.
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
Vienna, 1090
ana_abt_a@meduniwien.ac.at
Felix Kraft, Dr. med. univ.
About this study
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to
- Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival.
- 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.
- In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.
Read the detailed description
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to
- Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival.
- 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.
- 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
- Peritonitis, Sepsis, Septic Shock
- Being tested
- Pentaglobin®/Standard of Care
- Keywords
- Pentaglobin®, Personalized Medicine
- Medical subject headings
- Peritonitis, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentaglobin®/Standard of CareDrug
Standard-of-Care treatment + Pentaglobin®
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Standard of Care treatment |
| Verum arm | Active comparator | Standard of Care treatment + Pentaglobin® Receives: Drug: Pentaglobin®/Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 points are distributed per organ: Normal organ function: 0 points; organ dysfunction: 1 point; single organ failure: 2 points. A score > 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score are assigned a score of 10 points.
Measured: 7 days
Secondary outcomes (4)
Death within 28 days
Evaluation of death within 28-days.
Measured: 28 days
Death within 90 days
Evaluation of death within 90-days.
Measured: 90 days
Change in MOF Score from baseline to day 5
Change in MOF Score from baseline to day 5.
Measured: 5 days
Multi-Organ Failure (i.e., > 4 MOF points) on day 7
MOF (i.e., > 4 MOF points) on day 7.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start20 Nov 2017
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Biotest
- Responsible party
- Sponsor
- Investigators
- Gernot Marx, Univ.-Prof., Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334006
- Sponsor's protocol ID
- 15-167
- Other IDs
- 2024-513526-27-00, 2016-001788-34, 2016
- Acronym
- PEPPER
- Status last verified
- Jun 2026
- First submitted
- 27 Oct 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kujath P., Rodloff Peritonitis UNI-MED, 2001 ISBN 3-8999-549-5
Chang HJ, Lynm C, Glass RM. JAMA patient page. Sepsis. JAMA. 2010 Oct 27;304(16):1856. doi: 10.1001/jama.304.16.1856. No abstract available.
PubMed 20978264Harbarth S, Holeckova K, Froidevaux C, Pittet D, Ricou B, Grau GE, Vadas L, Pugin J; Geneva Sepsis Network. Diagnostic value of procalcitonin, interleukin-6, and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J Respir Crit Care Med. 2001 Aug 1;164(3):396-402. doi: 10.1164/ajrccm.164.3.2009052.
PubMed 11500339Heyland DK, Muscedere J, Drover J, Jiang X, Day AG; Canadian Critical Care Trials Group. Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials. Crit Care. 2011;15(2):R98. doi: 10.1186/cc10110. Epub 2011 Mar 18.
PubMed 21418560Muller B, Becker KL, Schachinger H, Rickenbacher PR, Huber PR, Zimmerli W, Ritz R. Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med. 2000 Apr;28(4):977-83. doi: 10.1097/00003246-200004000-00011.
PubMed 10809269Maruna P, Nedelnikova K, Gurlich R. Physiology and genetics of procalcitonin. Physiol Res. 2000;49 Suppl 1:S57-61.
PubMed 10984072Clec'h C, Fosse JP, Karoubi P, Vincent F, Chouahi I, Hamza L, Cupa M, Cohen Y. Differential diagnostic value of procalcitonin in surgical and medical patients with septic shock. Crit Care Med. 2006 Jan;34(1):102-7. doi: 10.1097/01.ccm.0000195012.54682.f3.
PubMed 16374163Monneret G, Doche C, Durand DV, Lepape A, Bienvenu J. Procalcitonin as a specific marker of bacterial infection in adults. Clin Chem Lab Med. 1998 Jan;36(1):67-8. doi: 10.1515/CCLM.1998.012. No abstract available.
PubMed 9594089Brunkhorst FM. [Sepsismarker--what is useful?]. Dtsch Med Wochenschr. 2008 Nov;133(48):2512-5. doi: 10.1055/s-0028-1100949. Epub 2008 Nov 19. No abstract available. German.
PubMed 19021084Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.
PubMed 16603606Van Snick J. Interleukin-6: an overview. Annu Rev Immunol. 1990;8:253-78. doi: 10.1146/annurev.iy.08.040190.001345. No abstract available.
PubMed 2188664Panacek EA, Marshall JC, Albertson TE, Johnson DH, Johnson S, MacArthur RD, Miller M, Barchuk WT, Fischkoff S, Kaul M, Teoh L, Van Meter L, Daum L, Lemeshow S, Hicklin G, Doig C; Monoclonal Anti-TNF: a Randomized Controlled Sepsis Study Investigators. Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab')2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels. Crit Care Med. 2004 Nov;32(11):2173-82. doi: 10.1097/01.ccm.0000145229.59014.6c.
PubMed 15640628Kuster H, Weiss M, Willeitner AE, Detlefsen S, Jeremias I, Zbojan J, Geiger R, Lipowsky G, Simbruner G. Interleukin-1 receptor antagonist and interleukin-6 for early diagnosis of neonatal sepsis 2 days before clinical manifestation. Lancet. 1998 Oct 17;352(9136):1271-7. doi: 10.1016/S0140-6736(98)08148-3.
PubMed 9788457Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, Hasper D, Keh D, Zuckermann H, Reinke P, Volk HD. Granulocyte-macrophage colony-stimulating factor to reverse sepsis-associated immunosuppression: a double-blind, randomized, placebo-controlled multicenter trial. Am J Respir Crit Care Med. 2009 Oct 1;180(7):640-8. doi: 10.1164/rccm.200903-0363OC. Epub 2009 Jul 9.
PubMed 19590022Schefold JC, von Haehling S, Corsepius M, Pohle C, Kruschke P, Zuckermann H, Volk HD, Reinke P. A novel selective extracorporeal intervention in sepsis: immunoadsorption of endotoxin, interleukin 6, and complement-activating product 5a. Shock. 2007 Oct;28(4):418-25. doi: 10.1097/shk.0b013e31804f5921.
PubMed 17558345
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
- ClinicalTrials.gov ID
- NCT03334006
- Acronym / sponsor ID
- PEPPER / 15-167
- Conditions
- Peritonitis, Sepsis, Septic Shock
- Keywords
- Pentaglobin®, Personalized Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Biotest
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to
- Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival.
- 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.
- In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.
Detailed description
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to
- Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Standard of Care treatment |
| Verum arm | Active comparator | Drug: Pentaglobin®/Standard of CareStandard of Care treatment + Pentaglobin® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentaglobin®/Standard of CareStandard-of-Care treatment + Pentaglobin® | Drug | Verum arm |
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.
Time frame: 7 days
The MOF score is determined in the morning. The following points are distributed per organ: Normal organ function: 0 points; organ dysfunction: 1 point; single organ failure: 2 points. A score > 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score are assigned a score of 10 points.
4 secondary outcomes
Death within 28 days
Time frame: 28 days
Death within 90 days
Time frame: 90 days
Change in MOF Score from baseline to day 5
Time frame: 5 days
Multi-Organ Failure (i.e., > 4 MOF points) on day 7
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- BackgroundKujath P., Rodloff Peritonitis UNI-MED, 2001 ISBN 3-8999-549-5
- Background: PubMed 20978264Chang HJ, Lynm C, Glass RM. JAMA patient page. Sepsis. JAMA. 2010 Oct 27;304(16):1856. doi: 10.1001/jama.304.16.1856. No abstract available.
- Background: PubMed 11500339Harbarth S, Holeckova K, Froidevaux C, Pittet D, Ricou B, Grau GE, Vadas L, Pugin J; Geneva Sepsis Network. Diagnostic value of procalcitonin, interleukin-6, and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J Respir Crit Care Med. 2001 Aug 1;164(3):396-402. doi: 10.1164/ajrccm.164.3.2009052.
- Background: PubMed 21418560Heyland DK, Muscedere J, Drover J, Jiang X, Day AG; Canadian Critical Care Trials Group. Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials. Crit Care. 2011;15(2):R98. doi: 10.1186/cc10110. Epub 2011 Mar 18.
- Background: PubMed 10809269Muller B, Becker KL, Schachinger H, Rickenbacher PR, Huber PR, Zimmerli W, Ritz R. Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med. 2000 Apr;28(4):977-83. doi: 10.1097/00003246-200004000-00011.
- Background: PubMed 10984072Maruna P, Nedelnikova K, Gurlich R. Physiology and genetics of procalcitonin. Physiol Res. 2000;49 Suppl 1:S57-61.
- Background: PubMed 16374163Clec'h C, Fosse JP, Karoubi P, Vincent F, Chouahi I, Hamza L, Cupa M, Cohen Y. Differential diagnostic value of procalcitonin in surgical and medical patients with septic shock. Crit Care Med. 2006 Jan;34(1):102-7. doi: 10.1097/01.ccm.0000195012.54682.f3.
- Background: PubMed 9594089Monneret G, Doche C, Durand DV, Lepape A, Bienvenu J. Procalcitonin as a specific marker of bacterial infection in adults. Clin Chem Lab Med. 1998 Jan;36(1):67-8. doi: 10.1515/CCLM.1998.012. No abstract available.
- Background: PubMed 19021084Brunkhorst FM. [Sepsismarker--what is useful?]. Dtsch Med Wochenschr. 2008 Nov;133(48):2512-5. doi: 10.1055/s-0028-1100949. Epub 2008 Nov 19. No abstract available. German.
- Background: PubMed 16603606Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.
- Background: PubMed 2188664Van Snick J. Interleukin-6: an overview. Annu Rev Immunol. 1990;8:253-78. doi: 10.1146/annurev.iy.08.040190.001345. No abstract available.
- Background: PubMed 15640628Panacek EA, Marshall JC, Albertson TE, Johnson DH, Johnson S, MacArthur RD, Miller M, Barchuk WT, Fischkoff S, Kaul M, Teoh L, Van Meter L, Daum L, Lemeshow S, Hicklin G, Doig C; Monoclonal Anti-TNF: a Randomized Controlled Sepsis Study Investigators. Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab')2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels. Crit Care Med. 2004 Nov;32(11):2173-82. doi: 10.1097/01.ccm.0000145229.59014.6c.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Center for Translational & Clinical Research (CTC-A) contact
Gernot Marx, Univ.-Prof. principal investigator
RWTH Aachen University
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Peritonitis and Sepsis, run by RWTH Aachen University at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Center for Translational & Clinical Research (CTC-A) (PEPPER@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334006, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.