Clinical trial NCT00859677: Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
Official title: Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Staphylococcal Infections
Keywords: HIV
Methicillin-resistant Staphylococcus aureus (MRSA)
HIV and Staphylococcus aureus infection
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Clinical Research Program
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-03-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References:
citation: 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.