Suspended

CHAT PilotCollaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

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What is being tested

Rosuvastatin or identical placebo

+ Placebo

Drug
Who is being recruted

Infections+1

+ RNA Virus Infections

+ Virus Diseases

Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2009
See protocol details

Summary

Principal SponsorCanadian Critical Care Trials Group
Last updated: February 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2009

Actual date on which the first participant was enrolled.

This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza

Principal SponsorCanadian Critical Care Trials Group
Last updated: February 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsRNA Virus InfectionsVirus DiseasesOrthomyxoviridae Infections

Criteria

Inclusion Criteria: Critically ill adult patients > 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection Requiring mechanical ventilation (invasive or non-invasive) Receiving antiviral therapy (any medication at any dose and for any intended duration) for < 72 hours Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1 Exclusion Criteria: Age < 16 years Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support Weight < 40 kg Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome) Rosuvastatin specific exclusions: Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin) Allergy or intolerance to statins Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay CK exceeds 10 times ULN or ALT exceeds 8 times the ULN Severe chronic liver disease (Child-Pugh Score 11-15) (see Appendix 6) Previous enrolment in this trial Pregnancy or breast feeding At the time of enrolment, patients must not have received >72 hours of antiviral therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug Both are crushed for administration

Group II

Placebo
Identical drug vehicle with no active agent

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St. Michael's Hospital

Toronto, CanadaOpen St. Michael's Hospital in Google Maps
SuspendedOne Study Center