STIP: Statin Trial for Influenza Patients

Gordon Bernard

Status: Terminated

Conditions: Influenza; Acute Respiratory Distress Syndrome; H1N1 Influenza

Treatments: Drug: Rosuvastatin (crestor); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00970606

STIP

Details and patient eligibility

About

To assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (ICU) admission due to respiratory distress.

Full description

Hypothesis: Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.

Enrollment: 7 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with suspected or confirmed influenza (Appendix A)

2. Requirement for ICU (or ICU step-down) admission due to respiratory distress defined as:

   • SaO2/FiO2 < 315 or PaO2/FiO2 < 300
   • Multiply by PB/760 (when altitude exceeds 51000 ft)
   • For FiO2 for non-intubated patients see Appendix B

Participants must receive the first dose of study drug within 48 hours following ICU admission for confirmed or suspected influenza or be excluded from participation in the study.

Exclusion criteria

1. No consent/inability to obtain consent
2. Age less than 13 years
3. Weight less than 40 kg
4. Unable to receive or unlikely to absorb enteral study drug (e.g. patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome)
5. Allergy or intolerance to statins*
6. Pregnancy or breast feeding
7. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir.
8. Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L
9. Requiring statin for underlying disease as determined by the patients attending physician team**.
10. Severe chronic liver disease (Child-Pugh Score 11-15)
11. Previous myocardial infarction or thrombotic stroke within the past 6 months 11.12. Any significant funding in the patient's medical history or physical or psychiatric exam prior to randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups, including a placebo group

Placebo tablet

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Rosuvastatin (crestor)

Experimental group

Description:

Experimental arm

Treatment:

Drug: Rosuvastatin (crestor)