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STIP: Statin Trial for Influenza Patients | Clinical Trials | Clareo Health

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STIP: Statin Trial for Influenza Patients

Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications

NCT00970606•Gordon Bernard

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

13 - No limit years

Sex

ALL

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)
+1 more criteria

Locations (21)

University of Arkansas

Little Rock, Alaska, United States

Maricopa Integrated Health System

Phoenix, Arizona, United States

Stanford

Stanford, California, United States

Northwestern University

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins Hospital

Baltiomore, Maryland, United States

Boston University

Boston, Massachusetts, United States

Baystate Medical Center

Springfiled, Massachusetts, United States

Columbia University

New York, New York, United States

Mt Sinai

New York, New York, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

July 1, 2011

Completion Date

July 1, 2011

Last Updated

March 22, 2017

Enrollment

ACTUAL participants

Conditions

Acute Respiratory Distress SyndromeInfluenzaH1N1 Influenza

Interventions

Rosuvastatin (crestor)

DRUG

Placebo

DRUG

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

NCT07291635

Influenza

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RECRUITINGPHASE3

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

NCT06094010

Influenza

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RECRUITING

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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STIP: Statin Trial for Influenza Patients

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

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