Expired Study
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Portsmouth, Virginia 23708


Purpose:

This study will prospectively evaluate the prevalence and incidence (over a two year period) of MRSA colonization and infection among HIV-infected military beneficiaries to determine predictors for the development of MRSA colonization and infection. This study will also investigate the utility of decolonization procedures for clearance of MRSA carriage and prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial sensitivities of isolates in this population will be determined.


Criteria:

Inclusion Criteria: - Adults (at least 18 years of age) who are HIV positive by a reactive screening (ELISA, EIA) and a confirmatory test (Western blot) and who are able to attend the study visits which are every 6 months (+/- 2 months), at the minimum Exclusion Criteria: - Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products. - Age less than 18 years. - Inability to remain in the study for the two year duration. - Pregnant or breastfeeding females. - Females who intend to become pregnant during the two year study time period. - Persons who are healthcare providers with direct patient contact.


Study is Available At:


Original ID:

IDCRP-003-RV210


NCT ID:

NCT00631566


Secondary ID:


Study Acronym:

MRSA


Brief Title:

Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Uniformed Services University of the Health Sciences


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

550


Enrollment Type:

Actual


Study Dates

Start Date:May 2007
Completion Date:October 2017
Completion Type:Actual
Primary Completion Date:May 2017
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 18, 2018
First Received Date:February 27, 2008
First Results Date:November 30, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.
Time Frame:at time of positive MRSA results
Safety Issues:False
Description:This outcome measure was not analyzed/reported due to resource limitation.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:This outcome measure was not analyzed/reported due to resource limitations.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
Time Frame:6 months
Safety Issues:False
Description:MRSA colonization at 6-months post-randomization

Study Interventions

Intervention Type:Drug
Name:Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHe
Description: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
Arm Name:1
Intervention Type:Drug
Name:Placebo
Description:Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.
Arm Name:2

Study Arms

Study Arm Type:No Intervention
Arm Name:No MRSA colonization
Study Arm Type:Placebo Comparator
Arm Name:2
Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Uniformed Services University of the Health Sciences
Agency Class:Other
Agency Type:Collaborator
Agency Name:Infectious Diseases Clinical Research Program

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Vyas KJ, Shadyab AH, Lin CD, Crum-Cianflone NF. Trends and factors associated with initial and recurrent methicillin-resistant Staphylococcus aureus (MRSA) skin and soft-tissue infections among HIV-infected persons: an 18-year study. J Int Assoc Provid AIDS Care. 2014 May-Jun;13(3):206-13. doi: 10.1177/2325957412473780. Epub 2013 Apr 19.
PMID:23603632
Reference Type:Results Reference
Citation:Crum-Cianflone NF, Shadyab AH, Weintrob A, Hospenthal DR, Lalani T, Collins G, Mask A, Mende K, Brodine SK, Agan BK; Infectious Disease Clinical Research Program HIV Working Group. Association of methicillin-resistant Staphylococcus aureus (MRSA) colonization with high-risk sexual behaviors in persons infected with human immunodeficiency virus (HIV). Medicine (Baltimore). 2011 Nov;90(6):379-89. doi: 10.1097/MD.0b013e318238dc2c.
PMID:22033452
Reference Type:Results Reference
Citation:Weintrob A, Bebu I, Agan B, Diem A, Johnson E, Lalani T, Wang X, Bavaro M, Ellis M, Mende K, Crum-Cianflone N. Randomized, Double-Blind, Placebo-Controlled Study on Decolonization Procedures for Methicillin-Resistant Staphylococcus aureus (MRSA) among HIV-Infected Adults. PLoS One. 2015 May 27;10(5):e0128071. doi: 10.1371/journal.pone.0128071. eCollection 2015.
PMID:26018036
Reference Type:Results Reference
Citation:Crum-Cianflone NF, Wang X, Weintrob A, Lalani T, Bavaro M, Okulicz JF, Mende K, Ellis M, Agan BK. Specific Behaviors Predict Staphylococcus aureus Colonization and Skin and Soft Tissue Infections Among Human Immunodeficiency Virus-Infected Persons. Open Forum Infect Dis. 2015 Mar 6;2(2):ofv034. doi: 10.1093/ofid/ofv034. eCollection 2015 Apr.
PMID:26380335

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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