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
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
Safety and Tolerability	All study visits (over 90 days following first dose)	Number of patients with treatment-emergent adverse events

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain