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CHAT Pilot: Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Sponsor
Canadian Critical Care Trials Group (Other)
Overall Status
Terminated
CT.gov ID
NCT01798602
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), The Physicians' Services Incorporated Foundation (Other), Public Health Agency of Canada (PHAC) (Other)
8
Enrollment
1
Location
2
Arms
8
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rosuvastatin or identical placebo
  • Drug: Placebo
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin

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

Drug: Rosuvastatin or identical placebo
Tablet crushed for administration via feeding tube
Other Names:
  • Crestor
  • Placebo

    		•
    Placebo Comparator: Placebo

    Identical drug vehicle with no active agent

    Drug: Placebo
    Identical placebo for rosuvastatin

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of eligible patients enrolled in the CHAT study [Over 6 month period or during H1N1 pandemic]

      This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic

    Secondary Outcome Measures

    1. Adherence to the medication administration regimen as outlined in the study protocol. [2 weeks]

    2. Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected. [6 months]

    3. The number of study withdrawals due to administration of open label statins and withdrawals of consent. [Up to 28 days or until hospital discharge]

    4. Recruitment rates by consent model. [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)

    2. Allergy or intolerance to statins

    3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Michael's Hospital Toronto Ontario Canada M5B 1W8

    Sponsors and Collaborators

    • Canadian Critical Care Trials Group
    • Canadian Institutes of Health Research (CIHR)
    • The Physicians' Services Incorporated Foundation
    • Public Health Agency of Canada (PHAC)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Canadian Critical Care Trials Group
    ClinicalTrials.gov Identifier:
    NCT01798602
    Other Study ID Numbers:
    • CCCTG
    First Posted:
    Feb 26, 2013
    Last Update Posted:
    Feb 26, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Canadian Critical Care Trials Group
    H1N1
    Rosuvastatin
    Additional relevant MeSH terms:
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Feb 26, 2013