Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Retapamulin 3 Days	Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin 5 Days	Retapamulin ointment, 1% 200 mg BID 5 days
Placebo	Placebo 200 mg BID for 5 days

Participant Flow:   Overall Study

	Retapamulin 3 Days	Retapamulin 5 Days	Placebo
STARTED	23	19	15
COMPLETED	20	18	13
NOT COMPLETED	3	1	2
Lost to Follow-up	2	1	0
Withdrawal by Subject	1	0	1
Physician Decision	0	0	1

Reporting Groups

	Description
Retapamulin 3 Days	Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin 5 Days	Retapamulin ointment, 1% 200 mg BID 5 days
Placebo	Placebo 200 mg BID for 5 days

Baseline Measures

	Retapamulin 3 Days	Retapamulin 5 Days	Placebo	Total
Number of Participants   [units: participants]	23	19	15	57
Age   [units: Years] Mean ± Standard Deviation	31.8  ± 10.80	35.8  ± 11.16	33.7  ± 12.67	33.6  ± 11.36
Gender   [units: participants]
Female	6	6	2	14
Male	17	13	13	43
Race/Ethnicity, Customized   [units: Participants]
African American/African Heritage	4	7	3	14
Asian - East Asian Heritage	0	0	1	1
Asian - Japanese Heritage	0	2	0	2
Asian - South East Asian Heritage	0	1	0	1
White	18	7	9	34
Mixed Race	1	2	2	5
Race/Ethnicity, Customized   [units: participants]
Hispanic or Latino	1	1	2	4
Not Hispanic or Latino	22	18	13	53
Efficacy population by carrier type (persistent vs intermittent)   [units: participants]
Persistent, Intent-to-Treat	17	16	13	46
Intermittent, Intent-to-Treat	1	2	0	3
Excluded from analysis	5	1	2	8

1.  Primary:

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing   [ Time Frame: Days 1 and 3 ]

2.  Primary:

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing   [ Time Frame: Day 5 ]

3.  Primary:

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing   [ Time Frame: Days 1 and 3 ]

4.  Primary:

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing   [ Time Frame: Day 5 ]

5.  Primary:

Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus   [ Time Frame: Day 12 ]

6.  Secondary:

Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3   [ Time Frame: Days 1 and 3 ]

7.  Secondary:

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5   [ Time Frame: Day 5 ]

8.  Secondary:

Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus   [ Time Frame: Days 7 and 33 ]

9.  Secondary:

Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status   [ Time Frame: Days 1, 7, 12, and 33 ]

10.  Secondary:

Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12   [ Time Frame: Days 7, 12, and 33 ]

11.  Secondary:

Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.   [ Time Frame: Screening Visits 1 (Day -42 to Day -14), 2 (Day -11 to Day -4), and 3 (Day -11 to Day -4) and Day 1 ]

12.  Secondary:

Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)   [ Time Frame: Days 7, 12, and 33 ]

13.  Other Pre-specified:

Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12   [ Time Frame: Days 7, 12, and 33. ]