STIP: Statin Trial for Influenza Patients

Influenza Clinical Trial

— STIP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00970606
• Other study ID #: STIP
• Status: Terminated
• Phase: N/A
• First received: August 31, 2009
• Last updated: June 28, 2013
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• H1N1 Influenza
• Influenza
• Influenza, Human
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
• Placebo
Placebo tablet identical to active therapy. 1 tablet per day

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltiomore	Maryland
United States	Boston University	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Erlanger	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	Metro Health	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	University of Arkansas	Little Rock	Alaska
United States	Intermountain	Murray	Utah
United States	Vanderbilt University	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	Mt Sinai	New York	New York
United States	Maricopa Integrated Health System	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Oregon	Portland	Oregon
United States	University of Texas	San Antonio	Texas
United States	Baystate Medical Center	Springfiled	Massachusetts
United States	Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Gordon Bernard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).	No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of >2000 participants planned/anticipated actually enrolled.	28 days	No