Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction

NCT ID: NCT02246595

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-12-31

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 primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.

Conditions

Severe Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CaCP29

dose escalating i.v. administration of CaCP29 (verum)

Group Type: ACTIVE_COMPARATOR

CaCP29

Intervention Type: BIOLOGICAL

Placebo

dose escalation mimicing i.v. placebo treatment:

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Interventions

CaCP29

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

IFX-1

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) not explained by other reasons. These criteria should be present within 12 hours prior to screening

4. Suspected or confirmed abdominal or pulmonary infection at screening

5. Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection

6. 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:

1. respiratory

2. renal

3. hematologic

4. metabolic

5. cardiovascular (occurred within the last three hours)

7. Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process

1. At least one of the sepsis related organ dysfunction detected at screening is still present

2. Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing

Exclusion Criteria

1. Sepsis of other primary cause than pulmonary or abdominal source

2. Weight > 130 kg at screening

3. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study

4. Patients receiving the following concomitant medication within 14 days prior to screening:

1. Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)

2. Proliferation inhibitors (e.g., everolimus, sirolimus)

3. Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)

4. High dose corticosteroids (e.g., > 50mg prednisolon per day or equivalent)

5. Patients receiving high dose immunoglobulins within 3 months prior to screening

6. Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count < 1,000/mm3 unless likely due to sepsis

7. General criteria:

1. Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women

2. 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

3. Participation in any interventional clinical trial within the last three months

4. Prior participation in this clinical trial

5. Patient is chronically bed-bound prior to the onset of sepsis

6. Known intravenous drug abuse

7. 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

8. No commitment to full aggressive life support (e.g., do not resuscitate order)

1. Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours

2. Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours

3. Organ dysfunctions are unlikely to be persistent for next three hours

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InflaRx GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bauer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Jena

Locations

Study Site

Aachen, , Germany

Study Site

Augsburg, , Germany

Study Site

Bad Saarow, , Germany

Study Site

Berlin, , Germany

Study Site

Göttingen, , Germany

Study Site

Greifswald, , Germany

Study Site

Hamburg, , Germany

Study Site

Jena, , Germany

Study Site

Kiel, , Germany

Study Site

Leipzig, , Germany

Study Site

Oldenburg, , Germany

Countries

Germany

Other Identifiers

2013-001037-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IFX-1-P2.1

Identifier Type: -

Identifier Source: org_study_id