Trial record 4 of 4 for:    niaid | Open Studies | Exclude Unknown | eczema atopic dermatitis

Host Factors in Invasive and Recurrent Staphylococcus Aureus Infection

This study is currently recruiting participants.
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00911430
First received: May 29, 2009
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

The incidence of community-associated (CA) staphylococcal infections, especially those caused by methicillin-resistant Staphylococcus aureus (MRSA), has increased dramatically in recent years. Although the majority of these infections are limited to the skin and soft tissue and thus not life threatening, the number of invasive cases in otherwise healthy individuals is increasing and some are fatal. As a first step toward understanding pathogenesis, there has been significant focus on elucidating the key CA-MRSA virulence factors. The relative significance of these factors is still being delineated. By comparison, there has been little focus on host factors associated with these invasive infections. In this protocol, we will recruit 100 otherwise healthy subjects with invasive staphylococcal infection, 50 otherwise healthy subjects with recurrent staphylococcal infections, and obtain samples from 150 unidentified healthy controls from the blood bank to investigate host immunologic factors predisposing people to staphylococcal infection. Subjects will receive standard of care treatment for acute or recurrent staphylococcal infections. The primary objective of this research is to identify host genetic factors that contribute to susceptibility or severity of community acquired staphylococcal diseases. We will use three experimental approaches to complete this objective: 1) expression microarray analyses of study population s (subjects and controls) white cells (neutrophils and peripheral blood mononuclear cells) at rest and stimulated with staphylococci, 2) evaluation of toll-like receptor (TLR) pathways in the study population s cells, and 3) evaluation of Th17 cells. The proposed research will address a key area of staphylococcal pathogenesis for which there is a striking lack of information. We fully anticipate that the research also will provide critical new information directly relevant to vaccine, diagnostics, and therapeutics development.


Condition
Staphylococcal Aureus Infection
Recurrent Staphylococcal Infection
Invasive Staphylococcal Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Host Factors in Invasive and Recurrent Staphylococcus Aureus Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: May 2009
Detailed Description:

The incidence of community-associated (CA) staphylococcal infections, especially those caused by methicillin-resistant Staphylococcus aureus (MRSA), has increased dramatically in recent years. Although the majority of these infections are limited to the skin and soft tissue and thus not life threatening, the number of invasive cases in otherwise healthy individuals is increasing and some are fatal. As a first step toward understanding pathogenesis, there has been significant focus on elucidating the key CA-MRSA virulence factors. The relative significance of these factors is still being delineated. By comparison, there has been little focus on host factors associated with these invasive infections. In this protocol, we will recruit 100 otherwise healthy subjects with invasive staphylococcal infection, 50 otherwise healthy subjects with recurrent staphylococcal infections, and obtain samples from 150 unidentified healthy controls from the blood bank to investigate host immunologic factors predisposing people to staphylococcal infection. Subjects will receive standard of care treatment for acute or recurrent staphylococcal infections. The primary objective of this research is to identify host genetic factors that contribute to susceptibility or severity of community acquired staphylococcal diseases. We will use three experimental approaches to complete this objective: 1) expression microarray analyses of study population s (subjects and controls) white cells (neutrophils and peripheral blood mononuclear cells) at rest and stimulated with staphylococci, 2) evaluation of toll-like receptor (TLR) pathways in the study population s cells, and 3) evaluation of Th17 cells. The proposed research will address a key area of staphylococcal pathogenesis for which there is a striking lack of information. We fully anticipate that the research also will provide critical new information directly relevant to vaccine, diagnostics, and therapeutics development.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age greater than or equal to 2 years.
    2. Current or past S. aureus infection, either invasive or soft tissue.
    3. Willingness to allow storage of blood and tissue samples for future use.
    4. Subjects will be eligible without regard to race, gender, or ethnic origin.

EXCLUSION CRITERIA:

  1. Infection with known HIV-1, HIV-2 as demonstrated by ELISA and Western blot or viral load testing.
  2. Evidence of intravenous drug abuse in the year prior to the first (or only) S. aureus infection.
  3. Previously known immunodeficiency syndrome.
  4. Evidence of active malignancy.
  5. Any condition that the investigators judge would compromise the results of the study.
  6. Diabetes mellitus.
  7. Evidence of healthcare-associated infection invasive device, history of surgery with implantation of artificial device in previous 12 months, history of surgery without device implantation in previous 12 month, or dialysis, hospitalization, or residence in long-term care facility in previous 12 months. An exception to these exclusion criteria is hospitalization for the acute S. aureus infection at the time of enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911430

Contacts
Contact: Pamela A Welch, R.N. (301) 402-0449 welchp@mail.nih.gov
Contact: Steven M Holland, M.D. (301) 402-7684 sholland@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Steven M Holland, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00911430     History of Changes
Other Study ID Numbers: 090157, 09-I-0157
Study First Received: May 29, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Staphylococcus Aureus (S. Areus)
Recurrent Staphylococcal Infection
Atopic Dermatitis
Immunodeficiency
Community Associated Staphylococcal Infection
Staphylococcal Infection
Invasive Staphylococcal Infection
Staph Infection

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 22, 2014