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Retapamulin for Reducing MRSA Nasal Carriage

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ClinicalTrials.gov Identifier: NCT01461668
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Methicillin-Resistant Staphylococcus Aureus
Interventions Drug: Retapamulin
Drug: Placebo
Enrollment 53
Recruitment Details Subjects were identified from MRSA samples tested for Mup-R from the UC Irvine Medical Center microbiology lab and from samples from participants who completed a separate clinical trial. Of 294 patients found to have mupirocin resistant isolates, 53 were consented and randomized. Three dropped out prior to any intervention.
Pre-assignment Details  
Arm/Group Title Retapamulin Placebo
Hide Arm/Group Description

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Retapamulin: Two times a day for 5 days

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Placebo: Two times a day for 5 days

Period Title: Overall Study
Started 27 26
Completed 25 25
Not Completed 2 1
Arm/Group Title Retapamulin Placebo Total
Hide Arm/Group Description

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Retapamulin: Two times a day for 5 days

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Placebo: Two times a day for 5 days

Total of all reporting groups
Overall Number of Baseline Participants 27 26 53
Hide Baseline Analysis Population Description
Number of participant totals reflect total subjects included in analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 26 participants 53 participants
60.3  (16.9) 59.0  (16.2) 59.7  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Female
17
  63.0%
11
  42.3%
28
  52.8%
Male
10
  37.0%
15
  57.7%
25
  47.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Hispanic or Latino
5
  18.5%
4
  15.4%
9
  17.0%
Not Hispanic or Latino
22
  81.5%
22
  84.6%
44
  83.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.7%
2
   7.7%
3
   5.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   7.4%
1
   3.8%
3
   5.7%
White
24
  88.9%
23
  88.5%
47
  88.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 27 participants 26 participants 53 participants
27 26 53
1.Primary Outcome
Title Proportion of Participants With MRSA Clearance
Hide Description Proportion of participants with MRSA clearance at the end of the follow up period
Time Frame 47 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The total number of participants analyzed include those that completed the study (through day 47).
Arm/Group Title Retapamulin Placebo
Hide Arm/Group Description:

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Retapamulin: Two times a day for 5 days

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Placebo: Two times a day for 5 days

Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
8
  32.0%
4
  16.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retapamulin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.08 to 1.86
Estimation Comments Confidence interval for the odds ratio is based upon the inversion Fisher's exact test
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Retapamulin Placebo
Hide Arm/Group Description

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Retapamulin: Two times a day for 5 days

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Placebo: Two times a day for 5 days

All-Cause Mortality
Retapamulin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Retapamulin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Retapamulin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Recruitment challenges from low yield of mupirocin-resistant MRSA. Trial suspended when funding concluded. Extensive efforts to acquire new sites and new funding to extend trial requirement were unsuccessful. Trial was closed and analysis completed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Raveena Singh
Organization: University of California Irvine
Phone: 949-824-9285
Responsible Party: Susan Huang, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01461668     History of Changes
Other Study ID Numbers: OCRT10049
First Submitted: October 26, 2011
First Posted: October 28, 2011
Results First Submitted: January 13, 2018
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018