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

Primary Purpose

HIV Infections, Staphylococcal Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
Placebo
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Methicillin-resistant Staphylococcus aureus (MRSA), HIV and Staphylococcus aureus infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Naval Medical Center San Diego/Infectious Disease Division
  • Walter Reed National Military Medical Center
  • San Antonio Military Medical Center (BAMC/WHMC)
  • Naval Medical Center Portsmouth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

1

2

No MRSA colonization

Arm Description

Outcomes

Primary Outcome Measures

The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
MRSA colonization at 6-months post-randomization

Secondary Outcome Measures

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.
To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue 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.
This outcome measure was not analyzed/reported due to resource limitation.

Full Information

First Posted
February 27, 2008
Last Updated
March 1, 2023
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID), US Military HIV Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT00631566
Brief Title
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
Acronym
MRSA
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID), US Military HIV Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Staphylococcal Infections
Keywords
HIV, Methicillin-resistant Staphylococcus aureus (MRSA), HIV and Staphylococcus aureus infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
No MRSA colonization
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
Intervention 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 seven days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.
Primary Outcome Measure Information:
Title
The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
Description
MRSA colonization at 6-months post-randomization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.
Description
This outcome measure was not analyzed/reported due to resource limitations.
Time Frame
At time of infection
Title
To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.
Description
This outcome measure was not analyzed/reported due to resource limitation.
Time Frame
at time of positive MRSA results

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Naval Medical Center San Diego/Infectious Disease Division
City
San Diego
State/Province
California
ZIP/Postal Code
92134-1201
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
San Antonio Military Medical Center (BAMC/WHMC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78236-9908
Country
United States
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708-2197
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23603632
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.
Results Reference
background
PubMed Identifier
22033452
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):379-389. doi: 10.1097/MD.0b013e318238dc2c.
Results Reference
result
PubMed Identifier
26018036
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.
Results Reference
result
PubMed Identifier
26380335
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.
Results Reference
result

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

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