Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)
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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 |
- Proportion of eligible patients enrolled in the CHAT Pilot Trial. [ Time Frame: anticipated 6 months (duration of pandemic) ] [ Designated as safety issue: No ]
- 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 |
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
Contacts and 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 | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Hopital Laval | |
| Quebec City, Quebec, Canada, G1V 4G5 | |
| Centre hospitalier universitaire de Sherbrooke (CHUS) | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| 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:
|
Critical Illness Influenza, Human Disease Attributes Pathologic Processes Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Rosuvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013