Trial Outcomes & Findings for STIP: Statin Trial for Influenza Patients (NCT NCT00970606)

Last Updated: 2017-03-22

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

28 days

Results posted on

2017-03-22

Participant Flow

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

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

STIP: Statin Trial for Influenza Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Tablet n=4 Participants Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day	Rosuvastatin (Crestor) n=3 Participants Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	43.03 years STANDARD_DEVIATION 12.89 • n=93 Participants	39.88 years STANDARD_DEVIATION 5.32 • n=4 Participants	41.68 years STANDARD_DEVIATION 9.76 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	4 participants n=93 Participants	3 participants n=4 Participants	7 participants n=27 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 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

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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Rosuvastatin (Crestor)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Tablet n=4 participants at risk Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day	Rosuvastatin (Crestor) n=3 participants at risk Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Hepatobiliary disorders Increased liver enzymes-AST/ALT	25.0% 1/4 • Number of events 1 • 28 days	0.00% 0/3 • 28 days

Additional Information

Gordon R. Bernard, MD, Associate Vice Chancellor for Research

Vanderbilt University Medical Center

Phone: 615-343-0077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place