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Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection (MRSA-2)
This study is currently recruiting participants.
Verified by Uniformed Services University of the Health Sciences, March 2009
First Received: March 10, 2009   No Changes Posted
Sponsors and Collaborators: Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT00859677
  Purpose

The purpose of this study is to investigate the role of Th17 cells in the pathogenesis of MRSA infections.


Condition
HIV Infections
Staphylococcal Infections

MedlinePlus related topics: AIDS Staphylococcal Infections
Drug Information available for: Methicillin Methicillin sodium
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Cross-Sectional
Official Title: Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Skin biopsy will be obtained.


Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859677

Contacts
Contact: Edith Lederman, MD 619-532-7475 edith.lederman@med.navy.mil
Contact: Nancy Crum-Cianflone, MD, MPH 619-532-7475 nancy.crum@med.navy.mil

Locations
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Alona Mask, MA     619-532-9812     alona.mask@med.navy.mil    
Sub-Investigator: Nancy Crum-Cianflone, MD, MPH            
United States, District of Columbia
Walter Reed Army Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20307
Contact: David Wallace     202-782-8754     david.wallace@amedd.army.mil    
Principal Investigator: Glenn Wortmann, MD            
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
Investigators
Principal Investigator: Edith Lederman, MD NMCSD
  More Information

No publications provided

Responsible Party: Infectious Diseases Clinical Research Program ( Edith Lederman, MD )
Study ID Numbers: IDCRP -023
Study First Received: March 10, 2009
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00859677     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:
HIV
Methicillin-resistant Staphylococcus aureus (MRSA)
HIV and Staphylococcus aureus infection

Study placed in the following topic categories:
Bacterial Infections
Sexually Transmitted Diseases, Viral
Disease Susceptibility
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
Staphylococcal Infections
Gram-Positive Bacterial Infections
Methicillin
HIV Infections
Sexually Transmitted Diseases
Genetic Predisposition to Disease
Retroviridae Infections

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Disease Attributes
Slow Virus Diseases
Infection
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Pathologic Processes
Methicillin
Therapeutic Uses
Genetic Predisposition to Disease
Retroviridae Infections
RNA Virus Infections
Disease Susceptibility
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Staphylococcal Infections
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 06, 2009