A phase II randomized, placebo-controlled, double-blind, dose controlled trial in patients suffering from early, newly developing abdominal or pulmonary derived septic organ dysfunction to evaluate safety, pharmacokinetics, pharmacodynamics and to estimate efficacy of the new humanized monoclonal i.v. administered antibody CaCP29

Phase 1

• Conditions: septic organ dysfunction; MedDRA version: 18.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-001037-40-DE
• Lead Sponsor: InflaRx GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-13
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Male or female patients = 18 years old
2. Written informed consent
3. Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS)
4. Suspected or confirmed abdominal or pulmonary infection
5. Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection which is also effective against N. meningitidis
6. At least one organ dysfunction due to sepsis
7. A reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. Sepsis of other primary cause than pulmonary or abdominal source
2. Weight > 130 kg
3. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
a. Infection where guidelines recommend a longer duration (i.e. more than 2 weeks) of antimicrobial therapy
b. meningitis
c. Life expectancy less than 6 months due to concomitant diseases
d. Significant hepatic impairment
e. Active hepatitis
f. Severe congestive heart failure
g. Severe central neurological impairment
h. Cardiopulmonary resuscitation in the 4 weeks prior to screening
4. Patients receiving the following concomitant medication within 14 days prior to screening:
a. Calcineurin inhibitors
b. Proliferation inhibitors
c. Anti-metabolites
d. High dose corticosteroids
5. Patients receiving high dose immunoglobulins (e.g., IVIG, Pentaglobin®) within 3 months prior to screening
6. Neutrocytopenia
6. General criteria
a. Pregnant or breast-feeding women
b. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
c. Participation in any interventional clinical trial within the last 3 months
d. Prior participation in this clinical trial
e. Patient is chronically bed-bound prior to the onset of sepsis
f. Known intravenous drug abuse
f. Employee at the study site, or spouse/partner or relative of any study staff
h. No commitment to full aggressive life support

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified