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

Study identifier:D0620C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients with Severe Sepsis and/or Septic Shock

Medical condition

Severe Sepsis

Phase

Phase 2

Healthy volunteers

Study drug

AZD9773, Placebo

Sex

All

Actual Enrollment

300

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Oct 2010

Primary Completion Date: 01 May 2012

Study Completion Date: 01 May 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2014 by AstraZeneca

Collaborators

Inclusion and exclusion 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:
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.

No locations available

Arms	Assigned Interventions
Experimental: 1 AZD9773 250/50 units/kg	Drug: AZD9773 A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days Other Name: CytoFab™
Experimental: 2 AZD9773 500/100 units/kg	Drug: AZD9773 A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days Other Name: CytoFab™
Placebo Comparator: 3	Drug: Placebo Placebo

Documents available

CSR-D0620C00003.pdf
Download
redacted-CSP-D0620C00003.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Gordon Bernard

Vanderbilt University