Status:
COMPLETED
Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction
Lead Sponsor:
InflaRx GmbH
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The pri...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria at screening:
- Male or female patients \>= 18 years old
- Written informed consent
- Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening
- Suspected or confirmed abdominal or pulmonary infection at screening
- Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection
- At least one of the following acute organ dysfunctions due to sepsis. Each organ dysfunction must have occurred within 12 hours prior to screening, cannot mainly be explained by other disease processes than sepsis and is judged by the investigator as being caused or directly related to an abdominal or pulmonary infectious focus:
- respiratory
- renal
- hematologic
- metabolic
- cardiovascular (occurred within the last three hours)
- Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process
- Key Exclusion Criteria at screening:
- Sepsis of other primary cause than pulmonary or abdominal source
- Weight \> 130 kg at screening
- Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
- Patients receiving the following concomitant medication within 14 days prior to screening:
- Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)
- Proliferation inhibitors (e.g., everolimus, sirolimus)
- Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)
- High dose corticosteroids (e.g., \> 50mg prednisolon per day or equivalent)
- Patients receiving high dose immunoglobulins within 3 months prior to screening
- Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count \< 1,000/mm3 unless likely due to sepsis
- General criteria:
- Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
- 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
- Participation in any interventional clinical trial within the last three months
- Prior participation in this clinical trial
- Patient is chronically bed-bound prior to the onset of sepsis
- Known intravenous drug abuse
- Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
- No commitment to full aggressive life support (e.g., do not resuscitate order)
- Inclusion Criteria at randomisation:
- At least one of the sepsis related organ dysfunction detected at screening is still present
- Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing
- Exclusion Criteria at randomisation:
- Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours
- Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours
- Organ dysfunctions are unlikely to be persistent for next three hours
Exclusion
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02246595
Start Date
April 1 2014
End Date
December 1 2015
Last Update
April 25 2016
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Study Site
Aachen, Germany
2
Study Site
Augsburg, Germany
3
Study Site
Bad Saarow, Germany
4
Study Site
Berlin, Germany