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Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)

Primary Purpose

Critically Ill, H1N1/Influenza Infection

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
Canadian Critical Care Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring critical care, H1N1/influenza infection, respiration, ventilation, artificial, critically ill patients, invasive mechanical ventilation, H1N1/influenza infection (suspected, probable or confirmed)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General Hospital
  • St. Paul's Hospital
  • Health Sciences Centre
  • St. Joseph's Healthcare
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital
  • Mount Sinai Hospital
  • Hopital Laval
  • Centre hospitalier universitaire de Sherbrooke (CHUS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug (Rosuvastatin) Crestor

Placebo

Arm Description

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.

An identical appearing placebo will be administered to patients in the second study arm.

Outcomes

Primary Outcome Measures

Proportion of eligible patients enrolled in the CHAT Pilot Trial.

Secondary Outcome Measures

Adherence to the medication regimen as outlined in the study protocol.
Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial
The number of study withdrawals due to administration of open label statins and consent withdrawals

Full Information

First Posted
December 16, 2009
Last Updated
February 20, 2013
Sponsor
Canadian Critical Care Trials Group
Collaborators
Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation, Public Health Agency of Canada (PHAC)
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1. Study Identification

Unique Protocol Identification Number
NCT01033955
Brief Title
Collaborative H1N1 Adjuvant Treatment Pilot Trial
Acronym
CHAT
Official Title
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
H1N1 pandemic concluded in early 2010
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Critical Care Trials Group
Collaborators
Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation, Public Health Agency of Canada (PHAC)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, H1N1/Influenza Infection
Keywords
critical care, H1N1/influenza infection, respiration, ventilation, artificial, critically ill patients, invasive mechanical ventilation, H1N1/influenza infection (suspected, probable or confirmed)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug (Rosuvastatin) Crestor
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An identical appearing placebo will be administered to patients in the second study arm.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
identical appearing encapsulated placebo.
Primary Outcome Measure Information:
Title
Proportion of eligible patients enrolled in the CHAT Pilot Trial.
Time Frame
anticipated 6 months (duration of pandemic)
Secondary Outcome Measure Information:
Title
Adherence to the medication regimen as outlined in the study protocol.
Time Frame
14 day treatment course
Title
Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial
Time Frame
90 days
Title
The number of study withdrawals due to administration of open label statins and consent withdrawals
Time Frame
anticipated 6 month study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Requiring mechanical ventilation (invasive or non-invasive) Receiving antiviral therapy (any medication at any dose and for any intended duration) for < or equal to 72 hours Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for influenza 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) Previous enrollment in this trial Pregnancy or breast feeding At the time of enrollment, patients must not have received >72 hours of antiviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Marshall, MD, FRCPS
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen EA Burns, MD,FRCPC,MSc
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3B 0Z3
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Hopital Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre hospitalier universitaire de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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Collaborative H1N1 Adjuvant Treatment Pilot Trial

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