Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial (CHAT Pilot)

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.

Study Overview

• Status: Terminated
• Conditions: H1N1 Influenza
• Intervention / Treatment: Drug: Rosuvastatin or identical placebo; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin; 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; Tablet crushed for administration via feeding tube; Other Names: Crestor; Placebo
Placebo Comparator: Placebo; Identical drug vehicle with no active agent	Drug: Placebo; Identical placebo for rosuvastatin

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Canadian Critical Care Trials Group
• Collaborators: Canadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated Foundation; Public Health Agency of Canada (PHAC)

Publications and helpful links

General Publications

• Burns KE, Chant C, Smith O, Cuthbertson B, Fowler R, Cook DJ, Kruger P, Webb S, Alhashemi J, Dominguez-Cherit G, Zala C, Rubenfeld GD, Marshall JC. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial. Trials. 2011 Mar 9;12:70. doi: 10.1186/1745-6215-12-70.

Helpful Links

• International Forum for Acute Care Trialists Website
• Canadian Critical Care Trials Group

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: February 22, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Rosuvastatin; H1N1
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: CCCTG