Collaborative H1N1 Adjuvant Treatment Pilot Trial

NCT01033955 | Terminated Phase 2 DMC

• 1 other identifier: 001 CHAT 2009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Critically Ill; H1N1/Influenza Infection

Keywords

critical care; H1N1/influenza infection; respiration; ventilation, artificial; critically ill patients; invasive mechanical ventilation; H1N1/influenza infection (suspected, probable or confirmed)

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible patients enrolled in the CHAT Pilot Trial.

  anticipated 6 months (duration of pandemic)

Secondary Outcomes (3)

• Adherence to the medication regimen as outlined in the study protocol.

  14 day treatment course

• Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial

  90 days

• The number of study withdrawals due to administration of open label statins and consent withdrawals

  anticipated 6 month study period

Study Arms (2)

Drug (Rosuvastatin) Crestor

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

An identical appearing placebo will be administered to patients in the second study arm.

Drug: Placebo

Interventions

Rosuvastatin DRUG

Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)

Also known as: Crestor

Drug (Rosuvastatin) Crestor

Placebo DRUG

identical appearing encapsulated placebo.

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

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

Study Sites (9)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3B 0Z3, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Aspiration

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John C Marshall, MD, FRCPS

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Karen EA Burns, MD,FRCPC,MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

CA (9)