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

Phase 2

Completed

• Conditions: Severe Sepsis; Septic Shock
• Interventions: Drug: Placebo; Drug: AZD9773

• Registration Number: NCT01145560
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Study Start: 2010-10
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-07-19
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-09-23
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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:

  1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
  2. Stage III or IV cancer.
  3. Haemopoietic or lymphoreticular malignancies not in remission.
  4. Receiving radiation therapy or chemotherapy.
  5. Stem cell, organ or bone marrow transplant in the past 6 months.
  6. Absolute neutrophil count <500 per μL.
  7. High dose steroids or other immunocompromising drugs.

• Concomitant diseases:

  1. Deep seated fungal infection or active tuberculosis.
  2. Cirrhosis with portal hypertension or Childs-Pugh Class C.
  3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
  4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
  5. Quadriplegia.
  6. Cardiac arrest in the past 30 days.
  7. New York Heart Association functional Class IV due to heart failure or any disorder.
  8. Burns over > 30% of body surface area.

• Medication and allergy disqualifications.

  1. Treatment with anti-TNF agents within the last 8 weeks.
  2. Previously received ovine derived products (CroFab™, DigiFab™).
  3. Sheep product allergy or allergy to latex, papain, chymopapain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	AZD9773	AZD9773 250/50 units/kg
2	AZD9773	AZD9773 500/100 units/kg

Primary Outcome Measures

Name	Time	Method
Ventilator-free Days (VFDs) Over 28 Days	Over 28 days following first dose	Number of ventilator-free days (VFDs)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	All study visits (over 90 days following first dose)	Number of patients with treatment-emergent adverse events
7-day Mortality	Over 7 days following first dose	Number of patients who died over 7 days
28-day Mortality	Over 28 days following first dose	Number of patients who died over 28 days

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain