Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

H1N1 Influenza Clinical Trial

— CHAT Pilot  

Official title:

Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798602
• Other study ID #: CCCTG
• Status: Terminated
• Phase: Phase 2
• First received: February 19, 2013
• Last updated: February 22, 2013
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2013
• Source: Canadian Critical Care Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• H1N1 Influenza

Intervention

Drug:
• Rosuvastatin or identical placebo
Tablet crushed for administration via feeding tube
• Placebo
Identical placebo for rosuvastatin

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Canadian Critical Care Trials Group	Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC), The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adherence to the medication administration regimen as outlined in the study protocol.		2 weeks	No
Secondary	Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.		6 months	No
Secondary	The number of study withdrawals due to administration of open label statins and withdrawals of consent.		Up to 28 days or until hospital discharge	No
Secondary	Recruitment rates by consent model.		6 months	No

External Links

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