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Collaborative H1N1 Adjuvant Treatment Pilot Trial

NCT01033955 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-02-21

No results posted yet for this study

Summary

Study Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80 patients in the general ICUs of 30 centres. Most patients will be recruited from within Canada; however cases will be recruited from international sites. This study will be conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG) and the International Forum for Acute Care Trialists (InFACT).

Conditions

  • Critically Ill
  • H1N1/Influenza Infection

Interventions

DRUG

Rosuvastatin

Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)

DRUG

Placebo

identical appearing encapsulated placebo.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV

  • Canadian Critical Care Trials Group

    lead OTHER

Principal Investigators

  • John C Marshall, MD, FRCPS · Unity Health Toronto

  • Karen EA Burns, MD,FRCPC,MSc · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT01033955 on ClinicalTrials.gov