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

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ClinicalTrials.gov Identifier: NCT01798602
Recruitment Status : Terminated (H1N1 pandemic concluded)
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Canadian Critical Care Trials Group

Study Description
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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
H1N1 Influenza 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Proportion of eligible patients enrolled in the CHAT study [ Time Frame: 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. [ Time Frame: 2 weeks ]
  2. Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected. [ Time Frame: 6 months ]
  3. The number of study withdrawals due to administration of open label statins and withdrawals of consent. [ Time Frame: Up to 28 days or until hospital discharge ]
  4. Recruitment rates by consent model. [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798602


Locations
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Canada, Ontario
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)
More Information
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Additional Information:

Publications:

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Responsible Party: Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT01798602    
Other Study ID Numbers: CCCTG
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Canadian Critical Care Trials Group:
H1N1
Rosuvastatin
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors