Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection (MRSA-2)

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

Study Overview

• Status: Completed
• Conditions: HIV Infections; Staphylococcal Infections

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-positive and negative patients with a recent screen for MRSA colonization or a history of MRSA infection will be asked to participate. Participants will be recruited by providers within the infectious disease clinics at the sites. In addtion, MRSA isolates will be monitored at the central laboratory and providers of patients with MRSA will be notified and asked to notify their patients of the opportunity to participate in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
1; HIV-positive and MRSA negative
2; HIV-positive and MRSA infected (skin/soft tissue)
3; HIV-positive and MRSA colonized
4; HIV-negative and MRSA negative
5; HIV-negative and MRSA infected (skin/soft tissue)
6; HIV-negative and MRSA colonized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin	1 year
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
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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Infectious Diseases Clinical Research Program

Publications and helpful links

General Publications

• 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):e1005580. doi: 10.1371/journal.ppat.1005580. eCollection 2016 Apr.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): August 26, 2016

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (Estimate): March 11, 2009

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Methicillin-resistant Staphylococcus aureus (MRSA); HIV and Staphylococcus aureus infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Disease Susceptibility; Staphylococcal Infections
• Other Study ID Numbers: IDCRP -023