Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Conditions
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H1N1 Influenza

Intervention / Treatment
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* Drug: Rosuvastatin or identical placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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) (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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug Both are crushed for administration | Drug: Rosuvastatin or identical placebo<br>* Tablet crushed for administration via feeding tube<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>Identical drug vehicle with no active agent | Drug: Placebo<br>* Identical placebo for rosuvastatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible patients enrolled in the CHAT study | This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic | Over 6 month period or during H1N1 pandemic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H1N1, Rosuvastatin