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

NCT00631566 | Completed Results DMC

• 1 other identifier: IDCRP-003-RV210
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections; Staphylococcal Infections

Keywords

HIV; Methicillin-resistant Staphylococcus aureus (MRSA); HIV and Staphylococcus aureus infection

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (3)

• 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.

  Every 6 months

• To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.

  At time of infection

• To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.

  at time of positive MRSA results

Study Arms (3)

1

EXPERIMENTAL

Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%

2

PLACEBO COMPARATOR

Drug: Placebo

No MRSA colonization

NO INTERVENTION

Interventions

Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% DRUG

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.

1

Placebo DRUG

Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Infectious Diseases Clinical Research Program: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• US Military HIV Research Program: collaborator

Study Sites (4)

Naval Medical Center San Diego/Infectious Disease Division

San Diego, California, 92134-1201, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

San Antonio Military Medical Center (BAMC/WHMC)

San Antonio, Texas, 78236-9908, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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.

  PMID: 22033452 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

HIV Infections; Staphylococcal Infections

Interventions

Mupirocin; Hexachlorophene; Triclosan

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Chlorophenols; Chlorobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Phenyl Ethers

Limitations and Caveats

Low rates of MRSA infections and SSTI during follow-up. Mostly males. Data for counts by arm other than nares for Outcome #2 are estimates from proportions and overall sample as these data were not available when record completed.

Results Point of Contact

• Title: Dr. Brian Agan, Deputy Science Director
• Organization: Infectious Disease Clinical Research Program, USUHS and HJF

bagan@idcrp.org

301-816-8446

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 3, 2023
• Results First Posted: August 16, 2018

Record last verified: 2023-03

Locations

US (4)