Overview

Collaborative H1N1 Adjuvant Treatment Pilot Trial

Status:
Terminated

Trial end date:
2010-07-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Canadian Critical Care Trials Group

Collaborators:

Canadian Institutes of Health Research (CIHR)
Public Health Agency of Canada (PHAC)
The Physicians' Services Incorporated Foundation

Treatments:

Rosuvastatin Calcium

Criteria

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