Clinical trial • Phase II • Immunology|Infectious Disease

Immunoglobulin A | Immunoglobulin G | Immunoglobulin M for Secondary peritonitis|Quaternary peritonitis|Sepsis|Septic shock

Phase II trial of Immunoglobulin A | Immunoglobulin G | Immunoglobulin M for Secondary peritonitis|Quaternary peritonitis|Sepsis|Septic shock. Randomised.

Overview

Trial Therapeutic Area
Immunology|Infectious Disease
Trial Disease
Secondary peritonitis|Quaternary peritonitis|Sepsis|Septic shock
Trial Stage
Phase II
Drug Modality
Other antibody|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
02-05-2024
First CTIS Authorization Date
29-05-2024

Trial design

Randomised Phase II trial across 13 sites in Austria, Germany.

Randomised
Yes
Target Sample Size
200
Trial Duration For Participant
90

Eligibility

Recruits 200 Vulnerable population selected. Minors (<18 years) are explicitly excluded. Consent may be provided by the patient and/or their legal representative (such as spouse, a proxy with effective power of attorney for health care, or a court-appointed guardian) or by a consultant; representative and emergency representation forms are provided (documents available in German)..

Pregnancy Exclusion
for female patients only: There is a pregnancy or the patient is breastfeeding.
Vulnerable Population
Vulnerable population selected. Minors (<18 years) are explicitly excluded. Consent may be provided by the patient and/or their legal representative (such as spouse, a proxy with effective power of attorney for health care, or a court-appointed guardian) or by a consultant; representative and emergency representation forms are provided (documents available in German).

Inclusion criteria

  • {"criterion_text":"- the patient has a diagnosis of secondary or quaternary peritonitis.\n- the time of source control is within 6 h of the indication (defined as the date and time of registration for surgery or minimally invasive procedure).\n- sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.\n- the SOFA score is ≥ 8.\n- the concentration of IL-6 is ≥ 1000 pg/ml.\n- antibiotic therapy is started within 12 h after admission to the intensive care unit.\n- the informed consent form has been signed by the patient himself and/or his legal representative (such as his spouse, a proxy with effective power of attorney for health care or a court-appointed guardian) or by a consultant."}

Exclusion criteria

  • {"criterion_text":"- the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.\n- the patient is institutionalised by court or regulatory order.\n- for female patients only: There is a pregnancy or the patient is breastfeeding.\n- the patient is a minor (<18 years).\n- The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg/dl or creatinine clearance ≤ 30 mL /min /1.73 m²).\n- the patient has acute, primarily non-infectious pancreatitis or mediastinitis.\n- the BMI is > 40.\n- the patient has a contraindication to the study medication.\n- patient has participated in another drug study within the last 30 days.\n- the patient has a dependent or employment relationship with the sponsor or investigator."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in multiple organ failure (MOF) score (determined in the organs lung, heart, kidney, liver, blood) from baseline to day 7 after source control, in the course of peritonitis.","definition_or_measurement_approach":"Change in MOF score determined in the organs lung, heart, kidney, liver and blood from baseline to day 7 after source control."}

Secondary endpoints

  • {"endpoint_text":"- Death within 28 days","definition_or_measurement_approach":"All-cause mortality assessed within 28 days."}
  • {"endpoint_text":"- Death within 90 days","definition_or_measurement_approach":"All-cause mortality assessed within 90 days."}
  • {"endpoint_text":"- Change in MOF score from baseline to day 5","definition_or_measurement_approach":"Change in MOF score from baseline to day 5."}
  • {"endpoint_text":"- Multi-organ failure (> 4 MOF points) on day 7","definition_or_measurement_approach":"Assessment of MOF score on day 7; threshold > 4 MOF points indicates multi-organ failure."}

Recruitment

Planned Sample Size
200
Recruitment Window Months
118
Consent Approach
Informed consent must be signed by the patient and/or the patient's legal representative (such as spouse, a proxy with effective power of attorney for health care, or a court-appointed guardian) or by a consultant. Specific representative and emergency consent forms and patient information/ICF documents are provided (documents available in German). Minors are excluded so no assent procedures described.

Geography

Total Number Of Sites
13
Total Number Of Participants
200

Austria

Latest Decision Or Authorization Date
19-11-2024
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Medical University Of Vienna
Department Name
Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
Contact Person Name
Felix Kraft
Contact Person Email
felix.kraft@meduniwien.ac.at

Germany

Latest Decision Or Authorization Date
01-04-2026
Number Of Sites
12
Number Of Participants
180

Sites

Site Name
Goethe University Frankfurt
Department Name
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Contact Person Name
Kai Zacharowski
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Contact Person Name
Markus Albertsmeier
Site Name
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department Name
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Contact Person Name
Michael Adamzik
Contact Person Email
michael.adamzik@kk-bochum.de
Site Name
Klinikum Nuernberg
Department Name
Klinik für Anästhesiologie und operative Intensivmedizin
Contact Person Name
Jens Kubitz
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Allgemein- und Viszeralchirurgie
Contact Person Name
Stefan Utzolino
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Operative Intensivmedizin und Intermediate Care
Contact Person Name
Gernot Marx
Contact Person Email
gmarx@ukaachen.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinik für Anästhesiologie und Intensivmedizin
Contact Person Name
Helene Häberle
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Intensivmedizin
Contact Person Name
Axel Nierhaus
Contact Person Email
nierhaus@uke.de
Site Name
Heinrich-Braun-Klinikum Zwickau gGmbH
Department Name
Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Contact Person Name
Udo Gottschaldt
Contact Person Email
udo.gottschaldt@hbk-zwickau.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik für Anästhesiologie
Contact Person Name
Alexander Dejaco
Contact Person Email
alexander.dejaco@ukr.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Anästhesiologie mit Intensivmedizin
Contact Person Name
Stefan Angermair
Contact Person Email
stefan.angermair@charite.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Anästhesiologie und Intensivmedizin
Contact Person Name
Thorsten Brenner
Contact Person Email
thorsten.brenner@uk-essen.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Aachen AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Contract research organisations

Name
CONVIDIA clinical research GmbH
Responsibilities
sponsorDuties code: 1; contact: contact@convidia.de; phone: +492512140130

Third parties

  • {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"sponsorDuties code: 10; contact: a.zapf@uke.de","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH","duties_or_roles":"sponsorDuties code: 4; contact: bjoern.koos@rub.de","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"CONVIDIA clinical research GmbH","duties_or_roles":"sponsorDuties code: 1; contact: contact@convidia.de","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Medical University Of Graz","duties_or_roles":"sponsorDuties code: 3; contact: office@randomizer.at","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
Pentaglobin 50 g/l Infusionslösung
Active Substance
Immunoglobulin A | Immunoglobulin G | Immunoglobulin M
Modality
Other antibody|Peptide/protein/enzyme
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Frequency
daily (max daily dose 7 millilitre(s)/kilogram)
Maximum Dose
35 millilitre(s)/kilogram total
Investigational Product Name
Pentaglobin 50 mg/ml Infusionslösung
Active Substance
Immunoglobulin A | Immunoglobulin G | Immunoglobulin M
Modality
Other antibody|Peptide/protein/enzyme
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Frequency
daily (max daily dose 7 millilitre(s)/kilogram)
Maximum Dose
35 millilitre(s)/kilogram total

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