Collaborative H1N1 Adjuvant Treatment Pilot Trial

Critically Ill Clinical Trial

— CHAT  

Official title:

Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01033955
• Other study ID #: 001 CHAT 2009
• Status: Terminated
• Phase: Phase 2
• First received: December 16, 2009
• Last updated: February 20, 2013
• Start date: January 2010
• Est. completion date: July 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

Study Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80 patients in the general ICUs of 30 centres. Most patients will be recruited from within Canada; however cases will be recruited from international sites. This study will be conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG) and the International Forum for Acute Care Trialists (InFACT).

Description:

Primary Objective: The primary objective of the CHAT Pilot Trial is to assess our ability to recruit the desired patient population (i.e., the proportion of eligible patients enrolled in the trial), and to conduct a scientifically rigorous international RCT under pandemic circumstances.

Secondary Objectives: To evaluate (i) adherence to the medication administration regimen. (ii) the ability for research staff to collect the required primary and secondary endpoints for the planned full CHAT trial, (iii) the number of study withdrawals due to administration of open-label statins and withdrawals of consent and (iv) the impact of the approved consent model on recruitment rates.

Study Methods (Overview): Using a web-based randomization system patients, research coordinators will assign critically ill adults treated with antiviral medication for < or equal to 72 hours and requiring mechanical ventilation to one of two treatment strategies (rosuvastatin or placebo) for 14 days. Given the need to recruit patients into the CHAT Trial under pandemic conditions, when family members may not be present to provide written informed consent, we will request either a waiver of consent or deferred consent from Research Ethics Boards (REBs) at participating centres. The Keenan Research Centre/Li Ka Shing Knowledge Institute (St Michael's Hospital, Toronto, Ontario) will be the study Methods Centre.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

1. Critically ill adult patients > or equal to 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed influenza infection

2. Requiring mechanical ventilation (invasive or non-invasive)

3. Receiving antiviral therapy (any medication at any dose and for any intended duration) for < or equal to 72 hours

4. Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for influenza

Exclusion Criteria:

1. Age < 16 years

2. Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support

3. Weight < 40 kg

4. Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)

5. Rosuvastatin specific exclusions:

• 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

6. Severe chronic liver disease (Child-Pugh Score 11-15)

7. Previous enrollment in this trial

8. Pregnancy or breast feeding

9. At the time of enrollment, patients must not have received >72 hours of antiviral therapy

Study Design

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• H1N1/Influenza Infection

Intervention

Drug:
• Rosuvastatin
Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
• Placebo
identical appearing encapsulated placebo.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Hopital Laval	Quebec City	Quebec
Canada	Centre hospitalier universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible patients enrolled in the CHAT Pilot Trial.		anticipated 6 months (duration of pandemic)	No
Secondary	Adherence to the medication regimen as outlined in the study protocol.		14 day treatment course	No
Secondary	Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial		90 days	No
Secondary	The number of study withdrawals due to administration of open label statins and consent withdrawals		anticipated 6 month study period	No