Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (NCT03334006) is a Phase 2 interventional studying Peritonitis and Sepsis, sponsored by Rwth Aachen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Peritonitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Peritonitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Pentaglobin®/Standard of Care

Standard-of-Care treatment + Pentaglobin®

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin

Vienna, Austria

Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Regensburg, Klinik für Anästhesiologie

Regensburg, Bavaria, Germany

Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin

Essen, North Rhine-Westphalia, Germany

Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin

Berlin, State of Berlin, Germany

Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care

Aachen, Germany

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie

Bochum, Germany

Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie

Dortmund, Germany

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie

Dresden, Germany

Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie

Düsseldorf, Germany

Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie

Frankfurt, Germany

Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie

Freiburg im Breisgau, Germany

Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin

Hamburg, Germany

Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin

Hanover, Germany

Universitätsklinikum Heidelberg, Anästhesiologische Klinik

Heidelberg, Germany

Klinikum Magdeburg, Klinik für Intensivmedizin

Magdeburg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Mainz, Germany

Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

München, Germany

Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin

Nuremberg, Germany

Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie

Zwickau, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03334006), the sponsor (Rwth Aachen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03334006 clinical trial studying?

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 tre… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03334006?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03334006?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03334006. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03334006. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.