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

NCT00859677 | Completed DMC

• 1 other identifier: IDCRP -023
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HIV Infections; Staphylococcal Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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.

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

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

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

  PMID: 27093273 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsy will be obtained.

MeSH Terms

Conditions

HIV Infections; Staphylococcal Infections

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: August 26, 2016
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (2)