Collaborative H1N1 Adjuvant Treatment pilot trial

Phase 2

Completed

• Conditions: Infections and Infestations; Influenza, virus not identified; Critically ill influenza A/H1N1 infection

• Registration Number: ISRCTN45190901
• Lead Sponsor: St Michael's Hospital (UK)

Brief Summary

2011 protocol in: https://doi.org/10.1186/1745-6215-12-70

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-08
• Study Completion: 2011-08-30
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Critically ill adult patients greater than 16 years of age (either sex) admitted to an adult intensive care unit (ICU) for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
2. Requiring mechanical ventilation (invasive or non-invasive)
3. Receiving antiviral therapy (any medication at any dose and for any intended duration) for less than 72 hours
4. Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for H1N1

Exclusion Criteria

1. Aged less than 16 years
2. Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support
3. Weight less than 40 kg
4. Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischaemia, infarction, short bowel syndrome)
5. Rosuvastatin specific exclusions:
5.1. Already receiving a statin (atorvastatin, lovastatin, simvastatin, pravastatin, rosuvastatin)
5.2. Allergy or intolerance to statins
5.3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, any protease inhibitor (including but not limited to lopinavir, ritonavir) or planned use of oral contraceptives or estrogen therapy during the Intensive Care Unit (ICU) stay
5.4. Creatine kinase (CK) exceeds 5,000 U/L or alanine aminotransferase (ALT) exceeds 8 times the upper limit of normal (ULN)
6. Severe chronic liver disease (Child-Pugh Score 11 - 15)
7. Previous enrolment in this trial
8. Pregnancy or breast feeding
9. At the time of enrolment, receipt of greater than 72 hours of antiviral therapy
10. Known or suspected clinically significant myositis or myopathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of eligible patients enrolled in the CHAT Pilot Trial. Feasibility for the pilot study will be assessed by metrics that reflect our capacity to ultimately recruit a representative sample of 1050 patients in the planned full CHAT trial. We will consider the study to be feasible if we recruit at least 30% (commonly used threshold in ICU studies) of all eligible patients in participating ICUs through careful review of site screening logs.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adherence to the medication administration regimen as outlined in the study protocol<br> 2. Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected<br> 3. The number of patients who receive open-label statins<br> 4. The number of consent withdrawals<br> 5. Recruitment rates by approved consent model<br><br> All outcomes will be measured upon termination of this pilot study. However, adherence to medication administration will be recorded daily on study days 1 through 14 for each study subject.<br>