Clinical trial NCT01798602: Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Official title: Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: H1N1 Influenza
Keywords: H1N1
Rosuvastatin
Lead sponsor: Canadian Critical Care Trials Group
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Physicians' Services Incorporated Foundation
name: Public Health Agency of Canada (PHAC)
First posted: 2013-02-26
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of eligible patients enrolled in the CHAT study
timeFrame: Over 6 month period or during H1N1 pandemic
Secondary outcomes:
measure: Adherence to the medication administration regimen as outlined in the study protocol.
timeFrame: 2 weeks
measure: Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.
timeFrame: 6 months
measure: The number of study withdrawals due to administration of open label statins and withdrawals of consent.
timeFrame: Up to 28 days or until hospital discharge
measure: Recruitment rates by consent model.
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: 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.