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Clinical Trials/EUCTR2013-001037-40-DE
EUCTR2013-001037-40-DE
Active, not recruiting
Phase 1

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 - SCIENS

InflaRx GmbH0 sites72 target enrollmentAugust 13, 2013
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
InflaRx GmbH
Enrollment
72
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 13, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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