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Personalized antibody therapy could tame deadly gut infections

NCT ID NCT03334006

Disease control Sponsor: RWTH Aachen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a personalized dose of Pentaglobin (an antibody treatment) after surgery helps people with severe abdominal infection (peritonitis) and sepsis recover better. Researchers will enroll 200 patients and track organ failure and survival. The goal is to find which patients benefit most, using blood markers to guide future treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis peritonitis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peritonitis Sepsis Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Berlin, State of Berlin, 12203, Germany

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

    RECRUITING

    Zwickau, 08060, Germany

  • Klinikum Magdeburg, Klinik für Intensivmedizin

    WITHDRAWN

    Magdeburg, 39130, Germany

  • Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin

    RECRUITING

    Nuremberg, 90419, Germany

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

    TERMINATED

    Dortmund, 44309, Germany

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

    RECRUITING

    München, 81377, Germany

  • Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin

    WITHDRAWN

    Hanover, 30625, Germany

  • Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin

    RECRUITING

    Vienna, 1090, Austria

  • Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care

    RECRUITING

    Aachen, 52074, Germany

  • Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie

    RECRUITING

    Frankfurt, 60590, Germany

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

    WITHDRAWN

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie

    WITHDRAWN

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

    Contact Email: •••••@•••••

  • Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg, Anästhesiologische Klinik

    WITHDRAWN

    Heidelberg, 69120, Germany

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

    RECRUITING

    Bochum, 44892, Germany

  • Universitätsklinikum Regensburg, Klinik für Anästhesiologie

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin

    TERMINATED

    Tübingen, Baden-Wurttemberg, 72076, Germany

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

    WITHDRAWN

    Mainz, 55131, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.