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

NCT ID: NCT00859677

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2016-08-26

Brief Summary

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

Detailed Description

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Conditions

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HIV Infections Staphylococcal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

HIV-positive and MRSA negative

No interventions assigned to this group

2

HIV-positive and MRSA infected (skin/soft tissue)

No interventions assigned to this group

3

HIV-positive and MRSA colonized

No interventions assigned to this group

4

HIV-negative and MRSA negative

No interventions assigned to this group

5

HIV-negative and MRSA infected (skin/soft tissue)

No interventions assigned to this group

6

HIV-negative and MRSA colonized

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Infectious Diseases Clinical Research Program

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Naval Medical Center San Diego

San Diego, California, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27093273 (View on PubMed)

Other Identifiers

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IDCRP -023

Identifier Type: -

Identifier Source: org_study_id

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