Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

NCT01798602 | Terminated Phase 2

• 1 other identifier: CCCTG
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

H1N1 Influenza

Keywords

H1N1; Rosuvastatin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Identical drug vehicle with no active agent

Drug: Placebo

Interventions

Rosuvastatin or identical placebo DRUG

Tablet crushed for administration via feeding tube

Also known as: Crestor, Placebo

Rosuvastatin

Placebo DRUG

Identical placebo for rosuvastatin

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 \> 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

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) (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

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 (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 21388549 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Orthomyxoviridae Infections

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 26, 2013
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

CA (1)