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

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631566
• Other study ID #: IDCRP-003-RV210
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: October 2017

Study information

• Verified date: March 2023
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Staphylococcal Infections

Intervention

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

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	San Antonio Military Medical Center (BAMC/WHMC)	San Antonio	Texas
United States	Naval Medical Center San Diego/Infectious Disease Division	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID), US Military HIV Research Program

Country where clinical trial is conducted

United States, 

References & Publications (4)

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) coloniza — View 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 F — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	At time of infection
Secondary	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.	at time of positive MRSA results