Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)

This study has been terminated.
(H1N1 pandemic concluded in early 2010)
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
ClinicalTrials.gov Identifier:
NCT01033955
First received: December 16, 2009
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Critically Ill
H1N1/Influenza Infection
Drug: Rosuvastatin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Resource links provided by NLM:


Further study details as provided by Canadian Critical Care Trials Group:

Primary Outcome Measures:
  • Proportion of eligible patients enrolled in the CHAT Pilot Trial. [ Time Frame: anticipated 6 months (duration of pandemic) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to the medication regimen as outlined in the study protocol. [ Time Frame: 14 day treatment course ] [ Designated as safety issue: No ]
  • Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The number of study withdrawals due to administration of open label statins and consent withdrawals [ Time Frame: anticipated 6 month study period ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033955

Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3B 0Z3
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
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)
Investigators
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
  More Information

No publications provided

Responsible Party: Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT01033955     History of Changes
Other Study ID Numbers: 001 CHAT 2009
Study First Received: December 16, 2009
Last Updated: February 20, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 20, 2014