Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01798602
Eligibility 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:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01798602
Study Brief:
Protocol Section:
NCT01798602