Trial Outcomes & Findings for Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment (NCT NCT00997139)

Results Overview

Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

216 participants

Primary outcome timeframe

Baseline

Results posted on

2015-01-05

Participant Flow

Only subjects with a positive Baseline culture continued on a treatment arm.

Participant milestones

Participant milestones
Measure	All Subjects
Overall Study STARTED	216
Overall Study Treated for Positive Baseline Culture	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	186

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=30 Participants Baseline culture positive for Staphylococcus aureus
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)

Outcome measures

Outcome measures
Measure	All Subjects n=216 Participants All subjects enrolled
Carrier Rate for Staphylococcus Aureus	20.8 percentage of subjects

PRIMARY outcome

Timeframe: 14 days

Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.

Outcome measures

Outcome measures
Measure	All Subjects n=28 Participants All subjects enrolled
MSSA Clearance Rate	57.1 percentage of subjects

PRIMARY outcome

Timeframe: 14 days

Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.

Outcome measures

Outcome measures
Measure	All Subjects n=2 Participants All subjects enrolled
MRSA Clearance Rate	0 percentage of subjects

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Unit Coordinator

Northwestern University Department of Dermatology

Phone: 312-695-6829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place