H1N1 Influenza
Conditions
Keywords
H1N1, Rosuvastatin
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.
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
Interventions
DRUGRosuvastatin or identical placebo
Tablet crushed for administration via feeding tube
DRUGPlacebo
Identical placebo for rosuvastatin
Sponsors
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Public Health Agency of Canada (PHAC)
Canadian Critical Care Trials Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible patients enrolled in the CHAT study | 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
| Measure | Time frame |
|---|---|
| Adherence to the medication administration regimen as outlined in the study protocol. | 2 weeks |
| Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected. | 6 months |
| The number of study withdrawals due to administration of open label statins and withdrawals of consent. | Up to 28 days or until hospital discharge |
| Recruitment rates by consent model. | 6 months |
Countries
Canada
Outcome results
None listed