NCT01145560

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
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
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-06-16
• Last updated: 2014-10-06
• Results posted: 2013-09-23

Locations

52 sites across 7 countries: Australia, Belgium, Canada, Czechia, Finland, France, Spain