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

This study has suspended participant recruitment.
(Enrollment was stopped due to staffing issues.)
Sponsor:
Collaborators:
Infectious Diseases Clinical Research Program
Information provided by (Responsible Party):
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00859677
First received: March 10, 2009
Last updated: October 7, 2014
Last verified: October 2014

March 10, 2009
October 7, 2014
March 2009
November 2010   (final data collection date for primary outcome 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00859677 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Skin biopsy will be obtained.

Non-Probability Sample

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.

  • HIV Infections
  • Staphylococcal Infections
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
December 2014
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00859677
IDCRP -023
Yes
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
  • Infectious Diseases Clinical Research Program
  • National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Uniformed Services University of the Health Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP