Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Aachen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

23 Feb 2018 → ongoing

Decision date (initial)

2024-05-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Universitätsklinikum Aachen AöR · Biotest AG

External identifiers

EU CT number

2024-513526-27-00

EudraCT number

2016-001788-34

ClinicalTrials.gov

NCT03334006

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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.

Secondary objectives 4

1. Death within 28 days
2. Death within 90 days
3. Change in MOF score from baseline to day 5
4. Multi-organ failure (> 4 MOF points) on day 7

Conditions and MedDRA coding

secondary or quaternary peritonitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. the patient has a diagnosis of secondary or quaternary peritonitis.
2. 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).
3. sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.
4. the SOFA score is ≥ 8.
5. the concentration of IL-6 is ≥ 1000 pg/ml.
6. antibiotic therapy is started within 12 h after admission to the intensive care unit.
7. 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 10

1. the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.
2. for female patients only: There is a pregnancy or the patient is breastfeeding.
3. the patient is a minor (<18 years).
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 BMI is > 40.
7. the patient has a contraindication to the study medication.
8. patient has participated in another drug study within the last 30 days.
9. the patient has a dependent or employment relationship with the sponsor or investigator.
10. the patient is institutionalised by court or regulatory order.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 4

1. Death within 28 days
2. Death within 90 days
3. Change in MOF score from baseline to day 5
4. Multi-organ failure (> 4 MOF points) on day 7

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Aachen AöR

Sponsor organisation

Universitaetsklinikum Aachen AöR

Address

Pauwelsstrasse 30

City

Aachen

Postcode

52074

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Aachen AöR

Contact name

Univ.-Prof. Dr. med. Gernot Marx

Public contact point

Organisation

Universitaetsklinikum Aachen AöR

Contact name

Dr. Rainer Schuckelt

Third parties 4

Locations

2 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications