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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

NCT01145560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-10-06

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Gordon Bernard, MD · Vanderbilt University

  • Warren Botnick, MD · Parexel

  • Justin Lindemann, MD · AstraZeneca

  • Wayne Dankner, MD · Parexel

  • Jiri Juchelka, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01145560 on ClinicalTrials.gov