Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection

HIV Infections Clinical Trial

— MRSA-2  

Official title:

Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859677
• Other study ID #: IDCRP -023
• Status: Completed
• Start date: March 2009
• Est. completion date: August 26, 2016

Study information

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

Clinical Trial Summary

The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the pathogenesis of MRSA infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 26, 2016
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

All participant inclusion criteria:

• Greater or equal to 18 years of age

• Willingness to undergo blood draw. Skin biopsy will be requested, but is optional

-AND-

HIV-positive and MRSA-negative Group:

• Documented positive HIV test result

• Negative colonization swabs for S. aureus within 14 days of enrollment

• No evidence of skin/soft tissue infection

HIV-positive and MRSA-Colonization Group:

• Documented positive HIV test result

• History of of colonization with MRSA w/in 14 days of study enrollment

HIV-positive and MRSA Infection Group:

• Documented positive HIV test result

• Skin/soft tissue infection with a positive wound culture showing MRSA within 7 days of enrollment

• MRSA infection is not associated with an intravenous catheter or other nosocomial procedure

HIV Negative groups:

• Same criteria used for the HIV-negative groups as listed above.

• No history of HIV infection.

• Willing to undergo an HIV blood test, which must have a negative result.

Exclusion Criteria:

• Women with positive urine pregnancy test within 7 days of study enrollment

• Women who are within 6 months of being postpartum or who are currently breastfeeding

• Subjects unable or unwilling to complete questionnaires and blood draw.

Related Conditions & MeSH terms

• Communicable Diseases
• Disease Susceptibility
• HIV Infections
• Infections
• Staphylococcal Infections

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (3)

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)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Utay NS, Roque A, Timmer JK, Morcock DR, DeLeage C, Somasunderam A, Weintrob AC, Agan BK, Estes JD, Crum-Cianflone NF, Douek DC. MRSA Infections in HIV-Infected People Are Associated with Decreased MRSA-Specific Th1 Immunity. PLoS Pathog. 2016 Apr 19;12(4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare distribution of Th17 cells and their functionality, in the peripheral blood of HIV-positive patients who are infected with MRSA with that of HIV-positive patients who are not colonized or infected with Staphylococcus aureus.		1 year
Secondary	Compare distribution of Th17 cells in the peripheral blood of groups of HIV-positive and HIV-negative participants who are colonized with MRSA as well as those who have a MRSA infection.		1 year
Secondary	Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin		1 year
Secondary	Compare Th17 cells in peripheral blood of HIV-negative participants with MRSA infection with that of HIV-negative subjects not colonized of infected with Staph aureus.		1 year
Secondary	Collect information on factors that may play a role in development of MRSA colonization/infection. Includes demographic, hygienic, exercise-related, and sexual factors which may contribute to MRSA.		1 year