STIP: Statin Trial for Influenza Patients

• Sponsor: Gordon Bernard (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00970606
• Collaborator: (none)
• Enrollment: 7
• Locations: 21
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome; Influenza; H1N1 Influenza	Drug: Rosuvastatin (crestor); Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo tablet Placebo	Drug: Placebo; Placebo tablet identical to active therapy. 1 tablet per day; Other Names: Placebo, sugar pill
Experimental: Rosuvastatin (crestor) Experimental arm	Drug: Rosuvastatin (crestor); 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge; Other Names: Crestor

Outcome Measures

Primary Outcome Measures

1. 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). [28 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas	Little Rock	Alaska	United States
2	Maricopa Integrated Health System	Phoenix	Arizona	United States
3	Stanford	Stanford	California	United States
4	Northwestern University	Chicago	Illinois	United States
5	University of Iowa	Iowa City	Iowa	United States
6	Johns Hopkins Hospital	Baltiomore	Maryland	United States
7	Boston University	Boston	Massachusetts	United States
8	Baystate Medical Center	Springfiled	Massachusetts	United States
9	Columbia University	New York	New York	United States
10	Mt Sinai	New York	New York	United States
11	Moses H. Cone Memorial Hospital	Greensboro	North Carolina	United States	27401
12	Metro Health	Cleveland	Ohio	United States
13	Ohio State University	Columbus	Ohio	United States
14	University of Oregon	Portland	Oregon	United States
15	University of Pittsburgh	Pittsburgh	Pennsylvania	United States
16	Medical University of South Carolina	Charleston	South Carolina	United States
17	Erlanger	Chattanooga	Tennessee	United States
18	Vanderbilt University	Nashville	Tennessee	United States	37232
19	University of Texas	San Antonio	Texas	United States
20	Intermountain	Murray	Utah	United States
21	University of Virginia	Charlottesville	Virginia	United States

Sponsors and Collaborators

• Gordon Bernard

Investigators

• Principal Investigator: Gordon R Bernard, M.D., Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00970606
• Other Study ID Numbers: STIP
• First Posted: Sep 2, 2009
• Last Update Posted: Mar 22, 2017
• Last Verified: Jun 1, 2013

• Keywords provided by Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center: ARDS; H1N1; Influenza; Statin
• Additional relevant MeSH terms: Influenza, Human; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Rosuvastatin Calcium

Study Results

Participant Flow

Recruitment Details	Study terminated due to lack of recruitment due to earlier than anticipated end to H1N1 flu season

Arm/Group Title	Placebo Tablet	Rosuvastatin (Crestor)
Arm/Group Description	Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day	Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Period Title: Overall Study
STARTED	4	3
COMPLETED	4	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo Tablet	Rosuvastatin (Crestor)	Total
Arm/Group Description	Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day	Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge	Total of all reporting groups
Overall Participants	4	3	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	3 100%	7 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.03 (12.89)	39.88 (5.32)	41.68 (9.76)
Sex: Female, Male (Count of Participants)
Female	1 25%	1 33.3%	2 28.6%
Male	3 75%	2 66.7%	5 71.4%
Region of Enrollment (participants) [Number]
United States	4 100%	3 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	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).
Description	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.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Only 7 participants were enrolled in this study designed for >2000. No formal anlaysis of outcomes was performed as tne n was too small to show any differences

Arm/Group Title	Placebo Tablet	Rosuvastatin (Crestor)
Arm/Group Description	Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day	Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Measure Participants	0	0

Adverse Events

Time Frame	28 days
Arm/Group Title	Placebo Tablet		Rosuvastatin (Crestor)
Arm/Group Description	Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day		Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
All Cause Mortality
	Placebo Tablet		Rosuvastatin (Crestor)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Tablet		Rosuvastatin (Crestor)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Tablet		Rosuvastatin (Crestor)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		0/3 (0%)
Hepatobiliary disorders
Increased liver enzymes-AST/ALT	1/4 (25%)	1	0/3 (0%)	0

Limitations/Caveats

Only able to enroll only 7 participants of >2000 planned/anticipated, leading to early termination of the study and therefore unable to perform statistical analysis with such a small sample size.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.