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Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00539994
Recruitment Status : Completed
First Posted : October 5, 2007
Results First Posted : August 20, 2010
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Infections, Bacterial
Interventions Drug: retapamulin
Drug: Retapamulin
Drug: Placebo
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo
Hide Arm/Group Description Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days Retapamulin ointment, 1% 200 mg BID 5 days Placebo 200 mg BID for 5 days
Period Title: Overall Study
Started 23 19 15
Completed 20 18 13
Not Completed 3 1 2
Reason Not Completed
Lost to Follow-up             2             1             0
Withdrawal by Subject             1             0             1
Physician Decision             0             0             1
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo Total
Hide Arm/Group Description Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days Retapamulin ointment, 1% 200 mg BID 5 days Placebo 200 mg BID for 5 days Total of all reporting groups
Overall Number of Baseline Participants 23 19 15 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 19 participants 15 participants 57 participants
31.8  (10.80) 35.8  (11.16) 33.7  (12.67) 33.6  (11.36)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 19 participants 15 participants 57 participants
Female
6
  26.1%
6
  31.6%
2
  13.3%
14
  24.6%
Male
17
  73.9%
13
  68.4%
13
  86.7%
43
  75.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 19 participants 15 participants 57 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 19 participants 15 participants 57 participants
Hispanic or Latino 1 1 2 4
Not Hispanic or Latino 22 18 13 53
Efficacy population by carrier type (persistent vs intermittent)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 19 participants 15 participants 57 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 Outcome
Title Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing
Hide Description Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Time Frame Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Concentration Population - included all subjects who underwent plasma PK sampling
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Overall Number of Participants Analyzed 14 10
Mean (Standard Deviation)
Unit of Measure: ng.h /mL
Day 1, n=5 and 2 0.8663  (1.77269) 0.3816  (0.89226)
Day 3, n=14 and 10 4.2802  (5.37822) 2.0881  (3.47126)
2.Primary Outcome
Title Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing
Hide Description Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Overall Number of Participants Analyzed 0 9
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1.8883  (3.05391)
3.Primary Outcome
Title Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing
Hide Description Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.
Time Frame Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Overall Number of Participants Analyzed 16 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1, n=10 and 3 0.4703  (0.34262) 0.3538  (0.27237)
Day 3, n=16 and 10 0.7893  (0.56984) 0.6185  (0.46093)
4.Primary Outcome
Title Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing
Hide Description Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Overall Number of Participants Analyzed 0 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.5547  (0.31469)
5.Primary Outcome
Title Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus
Hide Description Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2 and 3.
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Placebo 200 mg BID for 5 days
Overall Number of Participants Analyzed 16 14 13
Measure Type: Number
Unit of Measure: Percentage of participants
94 92 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retapamulin 3 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Retapamulin 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3
Hide Description 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.
Time Frame Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population of Intent-to-treat
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Overall Number of Participants Analyzed 16 10
Mean (Standard Deviation)
Unit of Measure: hours
Day 1, n=10 and 3 5.6000  (3.72529) 6.9933  (5.54812)
Day 3, n=16 and 10 3.8156  (2.26213) 2.4520  (1.49694)
7.Secondary Outcome
Title Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5
Hide Description 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.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population of Intent-to-treat
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Overall Number of Participants Analyzed 0 11
Mean (Standard Deviation)
Unit of Measure: hours
2.4118  (2.48003)
8.Secondary Outcome
Title Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus
Hide Description Subjects who tested positive as persistent carriers of S. Aureus who on Days 7 and 33 are negative and have eradicated of S. aureus.
Time Frame Days 7 and 33
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visits 1, 2 and 3.
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Placebo 200 mg BID for 5 days
Overall Number of Participants Analyzed 16 14 13
Measure Type: Number
Unit of Measure: Percentage of participants
Day 7 94 100 2
Day 33 75 86 4
9.Secondary Outcome
Title Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status
Hide Description 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
Time Frame Days 1, 7, 12, and 33
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Placebo 200 mg BID for 5 days
Overall Number of Participants Analyzed 16 14 13
Measure Type: Number
Unit of Measure: Percentage of participants
Culture positive Day 1, Nasal eradication Day 7 90 100 10
Culture negative Day 1, Nasal eradication Day 7 100 100 33
Culture positive Day 1, Nasal eradication Day 12 90 86 10
Culture negative Day 1, Nasal eradication Day 12 100 100 33
Culture positive Day 1, Nasal eradication Day 33 80 88 30
Culture negative Day 1, Nasal eradication Day 33 67 83 33
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Days 7, 12, and 33
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo Total
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 Days and Placebo 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Placebo 200 mg BID for 5 days
Total of all Groups
Overall Number of Participants Analyzed 16 14 13 43
Measure Type: Number
Unit of Measure: Percentage of participants
PC neg. D12, NC neg. D7, Recolonized D12 11 0 0 5
PC neg. D12, NC neg. D7 and D12, Recolonized D33 13 20 0 17
PC neg. D33, NC neg. D7, Recolonized D12 0 0 100 6
PC neg. D33, NC neg. D7 and D12, Recolonized D33 11 13 0 12
11.Secondary Outcome
Title Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Positive Nasal Culture for S. Aureus Positive Pharyngeal Culture for S. Aureus
Hide Arm/Group Description:
Screened subjects positive for S. aureus
Subjects who tested positive for S. aureus in the pharyngeal region.
Overall Number of Participants Analyzed 430 429
Measure Type: Number
Unit of Measure: participants
Screening 1, n=430, 429 135 150
Screening 2, n =104, 92 89 0
Screening 3, n=92 and 58 74 0
Day 1, n=58 and 58 53 37
12.Secondary Outcome
Title Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)
Hide Description The number of participants who tested negative for MRSA on days 7, 12, and 33.
Time Frame Days 7, 12, or 33.
Hide Outcome Measure Data
Hide Analysis Population Description
Screening Eligibility Population: only participants who provided nasal cultures at Days 7, 12, and 33 were analyzed.
Arm/Group Title MRSA
Hide Arm/Group Description:
Methicillin Resistant S. aureus.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
Day 7, n=12 12
Day 12, n=14 13
Day 33, n=17 17
13.Other Pre-specified Outcome
Title 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
Hide Description 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.
Time Frame Days 7, 12, and 33.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo Total
Hide Arm/Group Description:
Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
Retapamulin ointment, 1% 200 mg BID 5 days
Placebo 200 mg BID for 5 days
Total of all groups
Overall Number of Participants Analyzed 16 14 13 43
Measure Type: Number
Unit of Measure: Percentage of participants
PC pos. D12, NC neg. D7, Recolonized D12 0 33 50 18
PC pos. D12, NC neg. D7 and D12, Recolonized D33 33 0 0 22
PC pos. D33, NC neg. D7, Recolonized D12 17 17 0 15
PC pos. D33, NC neg. D7 and D12, Recolonized D33 40 25 0 30
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Retapamulin 3 Days Retapamulin 5 Days Placebo
Hide Arm/Group Description Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days Retapamulin ointment, 1% 200 mg BID 5 days Placebo 200 mg BID for 5 days
All-Cause Mortality
Retapamulin 3 Days Retapamulin 5 Days Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Retapamulin 3 Days Retapamulin 5 Days Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   1/19 (5.26%)   0/15 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Retapamulin 3 Days Retapamulin 5 Days Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/23 (26.09%)   10/19 (52.63%)   5/15 (33.33%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1/23 (4.35%)  0/19 (0.00%)  0/15 (0.00%) 
Cardiac disorders       
Palpitations  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Eye disorders       
Blepharitis  1/23 (4.35%)  0/19 (0.00%)  0/15 (0.00%) 
Gastrointestinal disorders       
Gastrooesophageal reflux disease  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
General disorders       
Asthenia  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Ill-defined disorder  0/23 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Infections and infestations       
Rhinitis  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Viral infection  0/23 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications       
Contusion  1/23 (4.35%)  0/19 (0.00%)  0/15 (0.00%) 
Post procedural complication  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Back pain  1/23 (4.35%)  0/19 (0.00%)  0/15 (0.00%) 
Nervous system disorders       
Headache  1  1/23 (4.35%)  3/19 (15.79%)  1/15 (6.67%) 
Burning Sensation  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Dizziness  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Dysgeusia  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Paraesthesia  1  0/23 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Paraesthesia  0/23 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders       
Nasal Discomfort  1  2/23 (8.70%)  1/19 (5.26%)  1/15 (6.67%) 
Rhinorrhoea  1  1/23 (4.35%)  1/19 (5.26%)  1/15 (6.67%) 
Sneezing  1  0/23 (0.00%)  2/19 (10.53%)  1/15 (6.67%) 
Epistaxis  1  0/23 (0.00%)  2/19 (10.53%)  0/15 (0.00%) 
Cough  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Nasal Congestion  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Pharyngolaryngeal Pain  1  0/23 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis allergic  0/23 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Pruritus allergic  0/23 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Urticaria  1/23 (4.35%)  0/19 (0.00%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Naderer OJ, Anderson M, Roberts K, Lou Y, Zhu J, Min S, Scangarella N, Shawar, R. Nasal Decolonization of Persistent Staphylococcus aureus Carriers with Twice Daily Retapamulin Treatment for 3 or 5 Days. Presentation Number L-1492. 48th ICAAC/46th IDSA Annual Meeting, Washington, DC, October 25-28, 2008.
Naderer OJ, Anderson M, Roberts K, Scangarella N, Shawar R, Mundy LM. Case detection of Staphylococcus aureus colonization: screening of the anterior nares (AN) and throat (T). Presentation Number K-3353. 48th Interscience Conference on Antimicrobial Agents and Chemotheraty (ICAAC)/46th Infectious Diseases Society of America (IDSA) Annual Meeting, Washington, DC, October 25-28, 2008.
Scangarella N, Naderer OJ, Anderson M, Roberts K, Sahm D, Shawar R. Antibacterial Activity of Retapamulin and Comparators Against Nasal and Pharyngeal Staphylococcus aureus Isolates Recovered from a Clinical Trial Investigating the Efficacy of Retapamulin in Nasal Decolonization. Presentation Number C1-3840. 48th ICAAC/46th IDSA Annual Meeting, Washington, DC, October 25-28, 2008.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00539994     History of Changes
Other Study ID Numbers: ALB110247
First Submitted: October 4, 2007
First Posted: October 5, 2007
Results First Submitted: January 9, 2009
Results First Posted: August 20, 2010
Last Update Posted: December 15, 2016