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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Retapamulin

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

Placebo

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


Participant Flow:   Overall Study
    Retapamulin   Placebo
STARTED   27   26 
COMPLETED   25   25 
NOT COMPLETED   2   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of participant totals reflect total subjects included in analysis.

Reporting Groups
  Description
Retapamulin

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

Placebo

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 Total of all reporting groups

Baseline Measures
   Retapamulin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   26   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.3  (16.9)   59.0  (16.2)   59.7  (16.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  63.0%      11  42.3%      28  52.8% 
Male      10  37.0%      15  57.7%      25  47.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   27   26   53 


  Outcome Measures

1.  Primary:   Proportion of Participants With MRSA Clearance   [ Time Frame: 47 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: ravsingh@uci.edu



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