At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 300 enrolled
Drug / intervention
AZD9773 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AZD9773 and Placebo for Severe Sepsis and Septic Shock. Completed, enrolled 300 participants across 52 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sepsis, Septic Shock
CountriesAustralia, Belgium, Canada, Czechia, Finland, France, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartOct 2010
Primary CompletionMay 2012
TodayJul 2026
First PostedJun 16, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.0 years ago
Interventions
AZD9773drug
A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
Placebodrug
Placebo