Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033955
Recruitment Status : Terminated (H1N1 pandemic concluded in early 2010)
First Posted : December 17, 2009
Last Update Posted : February 21, 2013
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

Brief 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).

Condition or disease Intervention/treatment Phase
Critically Ill H1N1/Influenza Infection Drug: Rosuvastatin Drug: Placebo Phase 2

Detailed Description:

Primary Objective: The primary objective of the CHAT Pilot Trial is to assess our ability to recruit the desired patient population (i.e., the proportion of eligible patients enrolled in the trial), and to conduct a scientifically rigorous international RCT under pandemic circumstances.

Secondary Objectives: To evaluate (i) adherence to the medication administration regimen. (ii) the ability for research staff to collect the required primary and secondary endpoints for the planned full CHAT trial, (iii) the number of study withdrawals due to administration of open-label statins and withdrawals of consent and (iv) the impact of the approved consent model on recruitment rates.

Study Methods (Overview): Using a web-based randomization system patients, research coordinators will assign critically ill adults treated with antiviral medication for < or equal to 72 hours and requiring mechanical ventilation to one of two treatment strategies (rosuvastatin or placebo) for 14 days. Given the need to recruit patients into the CHAT Trial under pandemic conditions, when family members may not be present to provide written informed consent, we will request either a waiver of consent or deferred consent from Research Ethics Boards (REBs) at participating centres. The Keenan Research Centre/Li Ka Shing Knowledge Institute (St Michael's Hospital, Toronto, Ontario) will be the study Methods Centre.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Drug (Rosuvastatin) Crestor
The first dose of encapsulated study drug or placebo (day 1) will be administered within 4 hours of randomization as a loading dose of 40 mg. The placebo will be identical in appearance to Rosuvastatin. Thereafter, doses of 20 mg will be administered daily starting on the next calendar day at 10 pm daily (+/- 4 hours) as a maintenance dose from days 2 to 14. If the patient is of Asian descent, is <18 years, or serum creatinine is greater than or equal to 248 μmol/L (2.8 mg/dL) dose adjustments will be made according to a dose adjustment algorithm.
Drug: Rosuvastatin
Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
Other Name: Crestor

Placebo Comparator: Placebo
An identical appearing placebo will be administered to patients in the second study arm.
Drug: Placebo
identical appearing encapsulated placebo.

Primary Outcome Measures :
  1. Proportion of eligible patients enrolled in the CHAT Pilot Trial. [ Time Frame: anticipated 6 months (duration of pandemic) ]

Secondary Outcome Measures :
  1. Adherence to the medication regimen as outlined in the study protocol. [ Time Frame: 14 day treatment course ]
  2. Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial [ Time Frame: 90 days ]
  3. The number of study withdrawals due to administration of open label statins and consent withdrawals [ Time Frame: anticipated 6 month study period ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. Critically ill adult patients > or equal to 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed influenza infection
  2. Requiring mechanical ventilation (invasive or non-invasive)
  3. Receiving antiviral therapy (any medication at any dose and for any intended duration) for < or equal to 72 hours
  4. Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for influenza

Exclusion Criteria:

  1. Age < 16 years
  2. Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support
  3. Weight < 40 kg
  4. Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)
  5. 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
  6. Severe chronic liver disease (Child-Pugh Score 11-15)
  7. Previous enrollment in this trial
  8. Pregnancy or breast feeding
  9. At the time of enrollment, patients must not have received >72 hours of antiviral therapy

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 identifier (NCT number): NCT01033955

Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3B 0Z3
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Hopital Laval
Quebec City, Quebec, Canada, G1V 4G5
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4
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)
Principal Investigator: John C Marshall, MD, FRCPS St. Michael's Hospital, Toronto
Principal Investigator: Karen EA Burns, MD,FRCPC,MSc St. Michael's Hospital, Toronto

Responsible Party: Canadian Critical Care Trials Group Identifier: NCT01033955     History of Changes
Other Study ID Numbers: 001 CHAT 2009
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Canadian Critical Care Trials Group:
critical care
H1N1/influenza infection
ventilation, artificial
critically ill patients
invasive mechanical ventilation
H1N1/influenza infection (suspected, probable or confirmed)

Additional relevant MeSH terms:
Influenza, Human
Critical Illness
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors