CHAT PilotCollaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Rosuvastatin or identical placebo
+ Placebo
Infections+1
+ RNA Virus Infections
+ Virus Diseases
Treatment Study
Summary
Study start date: December 1, 2009
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: 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 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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location