Phase 2
Completed N=300
A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock
Severe Sepsis · Septic Shock
Source: ClinicalTrials.gov NCT01145560 ↗
Enrolled (actual)
300
Serious AEs
29.0%
Results posted
Sep 2013
Primary outcomePrimary: Ventilator-free Days (VFDs) Over 28 Days — 21.0; 17.5; 19.0 Days
Summary
The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilator-free Days (VFDs) Over 28 Days |
21.0; 17.5; 19.0 | — |
| SECONDARY 7-day Mortality |
9; 9; 10 | — |
| SECONDARY 28-day Mortality |
15; 27; 20 | — |
| SECONDARY Safety and Tolerability |
86; 87; 92 | — |
Eligibility Criteria
Inclusion Criteria
- Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
- At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells [WBC])
- Cardiovascular or respiratory dysfunction.
Exclusion Criteria
- Immunocompromising comorbidities or concomitant medications:
- Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
- Stage III or IV cancer.
- Haemopoietic or lymphoreticular malignancies not in remission.
- Receiving radiation therapy or chemotherapy.
- Stem cell, organ or bone marrow transplant in the past 6 months.
- Absolute neutrophil count 30% of body surface area.
- Medication and allergy disqualifications.
- Treatment with anti-TNF agents within the last 8 weeks.
- Previously received ovine derived products (CroFab™, DigiFab™).
- Sheep product allergy or allergy to latex, papain, chymopapain.
Data sourced from ClinicalTrials.gov (NCT01145560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.