Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons (MRSA)
|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: NCT00631566|
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Staphylococcal Infections||Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prospective Study on the Incidence, Predictors, and Characteristics of Methicillin-Resistant Staphylococcus Aureus Infections and a Randomized, Double-Blind Study on Decolonization Procedures for Prevention of MRSA Infections Among HIV-Infected Persons|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||October 2017|
Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).
pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.
Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.
|Placebo Comparator: 2||
Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.
|No Intervention: No MRSA colonization|
- The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization [ Time Frame: 6 months ]MRSA colonization at 6-months post-randomization
- To Determine the Prevalence and Incidence of MRSA Colonization of the Nares, Throat, Perirectal, Axilla, and Groin Areas Among HIV Infected Patients and to Study Changes in the Colonization Rates Over Time. [ Time Frame: Every 6 months ]
- To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection. [ Time Frame: At time of infection ]This outcome measure was not analyzed/reported due to resource limitations.
- To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population. [ Time Frame: at time of positive MRSA results ]This outcome measure was not analyzed/reported due to resource limitation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631566
|United States, California|
|Naval Medical Center San Diego/Infectious Disease Division|
|San Diego, California, United States, 92134-1201|
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|United States, Texas|
|San Antonio Military Medical Center (BAMC/WHMC)|
|San Antonio, Texas, United States, 78236-9908|
|United States, Virginia|
|Naval Medical Center Portsmouth|
|Portsmouth, Virginia, United States, 23708-2197|