Trial Outcomes & Findings for Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus (NCT NCT00539994)
NCT ID: NCT00539994
Last Updated: 2016-12-15
Results Overview
Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Days 1 and 3
Results posted on
2016-12-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
15
|
|
Overall Study
COMPLETED
|
20
|
18
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
Baseline characteristics by cohort
| Measure |
Retapamulin 3 Days
n=23 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
|
Retapamulin 5 Days
n=19 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=15 Participants
Placebo 200 mg BID for 5 days
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.8 Years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
35.8 Years
STANDARD_DEVIATION 11.16 • n=7 Participants
|
33.7 Years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
33.6 Years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
13 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Efficacy population by carrier type (persistent vs intermittent)
Persistent, Intent-to-Treat
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Efficacy population by carrier type (persistent vs intermittent)
Intermittent, Intent-to-Treat
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Efficacy population by carrier type (persistent vs intermittent)
Excluded from analysis
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 3Population: Pharmacokinetic (PK) Concentration Population - included all subjects who underwent plasma PK sampling
Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Outcome measures
| Measure |
Retapamulin 3 Days
n=14 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=10 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing
Day 1, n=5 and 2
|
0.8663 ng.h /mL
Standard Deviation 1.77269
|
0.3816 ng.h /mL
Standard Deviation 0.89226
|
—
|
—
|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing
Day 3, n=14 and 10
|
4.2802 ng.h /mL
Standard Deviation 5.37822
|
2.0881 ng.h /mL
Standard Deviation 3.47126
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling
Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Outcome measures
| Measure |
Retapamulin 3 Days
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=9 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing
|
—
|
1.8883 ng.h/mL
Standard Deviation 3.05391
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 3Population: Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling
Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=10 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing
Day 1, n=10 and 3
|
0.4703 ng/mL
Standard Deviation 0.34262
|
0.3538 ng/mL
Standard Deviation 0.27237
|
—
|
—
|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing
Day 3, n=16 and 10
|
0.7893 ng/mL
Standard Deviation 0.56984
|
0.6185 ng/mL
Standard Deviation 0.46093
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling
Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL
Outcome measures
| Measure |
Retapamulin 3 Days
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=11 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing
|
—
|
0.5547 ng/mL
Standard Deviation 0.31469
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 12Population: Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2 and 3.
Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=14 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=13 Participants
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus
|
94 Percentage of participants
|
92 Percentage of participants
|
15 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 3Population: Per Protocol Population of Intent-to-treat
Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=10 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3
Day 1, n=10 and 3
|
5.6000 hours
Standard Deviation 3.72529
|
6.9933 hours
Standard Deviation 5.54812
|
—
|
—
|
|
Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3
Day 3, n=16 and 10
|
3.8156 hours
Standard Deviation 2.26213
|
2.4520 hours
Standard Deviation 1.49694
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5Population: Per Protocol Population of Intent-to-treat
Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.
Outcome measures
| Measure |
Retapamulin 3 Days
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=11 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5
|
—
|
2.4118 hours
Standard Deviation 2.48003
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7 and 33Population: Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visits 1, 2 and 3.
Subjects who tested positive as persistent carriers of S. Aureus who on Days 7 and 33 are negative and have eradicated of S. aureus.
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=14 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=13 Participants
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus
Day 7
|
94 Percentage of participants
|
100 Percentage of participants
|
2 Percentage of participants
|
—
|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus
Day 33
|
75 Percentage of participants
|
86 Percentage of participants
|
4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 12, and 33Population: Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and who were Persistent Nasal carriers who were both positive and negative carriers of S. aureus in the Pharyngeal region.
Comparison of nasal S. aureus eradication in persistent carrier subjects on 7, 12, and 33 days after treatment stratified by S. aureus carriage in the pharyngeal area
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=14 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=13 Participants
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Culture positive Day 1, Nasal eradication Day 7
|
90 Percentage of participants
|
100 Percentage of participants
|
10 Percentage of participants
|
—
|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Culture negative Day 1, Nasal eradication Day 7
|
100 Percentage of participants
|
100 Percentage of participants
|
33 Percentage of participants
|
—
|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Culture positive Day 1, Nasal eradication Day 12
|
90 Percentage of participants
|
86 Percentage of participants
|
10 Percentage of participants
|
—
|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Culture negative Day 1, Nasal eradication Day 12
|
100 Percentage of participants
|
100 Percentage of participants
|
33 Percentage of participants
|
—
|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Culture positive Day 1, Nasal eradication Day 33
|
80 Percentage of participants
|
88 Percentage of participants
|
30 Percentage of participants
|
—
|
|
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Culture negative Day 1, Nasal eradication Day 33
|
67 Percentage of participants
|
83 Percentage of participants
|
33 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 7, 12, and 33Population: Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3 and those who were NEGATIVE for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.
Percentage of subjects that were recolonized on Day 12 (D12) and Day 33 (D33) that were negative (neg.) for S. Aureus in the Pharyngeal region on days 12 or 33 and Negative in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=14 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=13 Participants
Placebo 200 mg BID for 5 days
|
Total
n=43 Participants
Total of all Groups
|
|---|---|---|---|---|
|
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
PC neg. D12, NC neg. D7, Recolonized D12
|
11 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
5 Percentage of participants
|
|
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
PC neg. D12, NC neg. D7 and D12, Recolonized D33
|
13 Percentage of participants
|
20 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
|
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
PC neg. D33, NC neg. D7, Recolonized D12
|
0 Percentage of participants
|
0 Percentage of participants
|
100 Percentage of participants
|
6 Percentage of participants
|
|
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
PC neg. D33, NC neg. D7 and D12, Recolonized D33
|
11 Percentage of participants
|
13 Percentage of participants
|
0 Percentage of participants
|
12 Percentage of participants
|
SECONDARY outcome
Timeframe: Screening Visits 1 (Day -42 to Day -14), 2 (Day -11 to Day -4), and 3 (Day -11 to Day -4) and Day 1Population: Screening Population (participants who had anterior nares swab obtained for S. aureus culture) was analyzed for Screening Visit (SV) 1. Only subjects who had positive cultures for S. aureus at SV 1 were allowed to continue to SV 2 and 3. The Safety Population (participants who received at least one dose of study drug) was analyzed at Day 1.
All participants were assessed for nasal and pharyngeal carriage at Screening Visits 1, 2, and 3. Participants were randomized into the study only if they had positive cultures at screening visit 1 and screening visit 2 and/or screening visit 3. Day 1 data were collected only for those participants who were randomized into the study.
Outcome measures
| Measure |
Retapamulin 3 Days
n=430 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=429 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.
Screening 1, n=430, 429
|
135 participants
|
150 participants
|
—
|
—
|
|
Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.
Screening 2, n =104, 92
|
89 participants
|
0 participants
|
—
|
—
|
|
Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.
Screening 3, n=92 and 58
|
74 participants
|
0 participants
|
—
|
—
|
|
Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.
Day 1, n=58 and 58
|
53 participants
|
37 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7, 12, or 33.Population: Screening Eligibility Population: only participants who provided nasal cultures at Days 7, 12, and 33 were analyzed.
The number of participants who tested negative for MRSA on days 7, 12, and 33.
Outcome measures
| Measure |
Retapamulin 3 Days
n=17 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
Placebo 200 mg BID for 5 days
|
Total
Total of all Groups
|
|---|---|---|---|---|
|
Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)
Day 7, n=12
|
12 participants
|
—
|
—
|
—
|
|
Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)
Day 12, n=14
|
13 participants
|
—
|
—
|
—
|
|
Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)
Day 33, n=17
|
17 participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 7, 12, and 33.Population: Per Protocol Population: Persistant Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and those who were Positive for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.
All subjects were positive (pos.) for S. Aureus in the Pharyngeal region on days 12 or 33 (D12 and D33) and Negative (neg.) in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.
Outcome measures
| Measure |
Retapamulin 3 Days
n=16 Participants
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
|
Retapamulin 5 Days
n=14 Participants
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=13 Participants
Placebo 200 mg BID for 5 days
|
Total
n=43 Participants
Total of all Groups
|
|---|---|---|---|---|
|
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
PC pos. D12, NC neg. D7, Recolonized D12
|
0 Percentage of participants
|
33 Percentage of participants
|
50 Percentage of participants
|
18 Percentage of participants
|
|
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
PC pos. D12, NC neg. D7 and D12, Recolonized D33
|
33 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
22 Percentage of participants
|
|
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
PC pos. D33, NC neg. D7, Recolonized D12
|
17 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
15 Percentage of participants
|
|
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
PC pos. D33, NC neg. D7 and D12, Recolonized D33
|
40 Percentage of participants
|
25 Percentage of participants
|
0 Percentage of participants
|
30 Percentage of participants
|
Adverse Events
Retapamulin 3 Days
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Retapamulin 5 Days
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Retapamulin 3 Days
n=23 participants at risk
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
|
Retapamulin 5 Days
n=19 participants at risk
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=15 participants at risk
Placebo 200 mg BID for 5 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
Other adverse events
| Measure |
Retapamulin 3 Days
n=23 participants at risk
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
|
Retapamulin 5 Days
n=19 participants at risk
Retapamulin ointment, 1% 200 mg BID 5 days
|
Placebo
n=15 participants at risk
Placebo 200 mg BID for 5 days
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
8.7%
2/23
|
5.3%
1/19
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
1/23
|
5.3%
1/19
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/23
|
10.5%
2/19
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23
|
10.5%
2/19
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Nervous system disorders
Headache
|
4.3%
1/23
|
15.8%
3/19
|
6.7%
1/15
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23
|
0.00%
0/19
|
6.7%
1/15
|
|
General disorders
Asthenia
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
General disorders
Ill-defined disorder
|
0.00%
0/23
|
0.00%
0/19
|
6.7%
1/15
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Infections and infestations
Viral infection
|
0.00%
0/23
|
0.00%
0/19
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23
|
0.00%
0/19
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23
|
0.00%
0/19
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/23
|
0.00%
0/19
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/23
|
0.00%
0/19
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.3%
1/23
|
0.00%
0/19
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.3%
1/23
|
0.00%
0/19
|
0.00%
0/15
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
|
Eye disorders
Blepharitis
|
4.3%
1/23
|
0.00%
0/19
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23
|
5.3%
1/19
|
0.00%
0/15
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER