Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Phase 2TerminatedNCT01798602

Canadian Critical Care Trials Group8 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

H1N1 Influenza

Interventions

Rosuvastatin or identical placeboDRUG

Tablet crushed for administration via feeding tube

PlaceboDRUG

Identical placebo for rosuvastatin

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: Over 6 month period or during H1N1 pandemic

Secondary Outcomes

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

Time frame: 2 weeks

Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.

Time frame: 6 months

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

Time frame: Up to 28 days or until hospital discharge

Recruitment rates by consent model.

Time frame: 6 months

Data from ClinicalTrials.gov

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