Status:
COMPLETED
Human Immunity Against Staphylococcus Aureus Skin Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Staphylococcus Aureus Skin Infection
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
Brief Summary
Background: \- Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory system. Sometimes people who get sick with staph infection do not get better with standard treatme...
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. Skin an...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participants must either:
- Have documentation of a proven or suspected immune defect or a history of invasive infection or recurrent (2 or more) skin infections with S. aureus (patient population); or
- Not have evidence of an immune defect or history of invasive or recurrent S. aureus infections (healthy volunteers).
- Participants must be between 2 and 65 years old (inclusive).
- Participants must be willing to allow storage of blood, DNA, RNA, bacterial and fungal cultures, and other tissue samples for future research. Some research blood may not be required of healthy volunteers, except at the discretion of the Principal Investigator (PI).
- EXCLUSION CRITERIA:
- The following exclusion criteria apply to all participants:
- Current chemotherapy or underlying malignancy.
- Current oral steroids.
- Individuals with any condition that, in the opinion of the investigator, contraindicates participation in the study will be excluded.
- The following exclusion criteria apply to adult participants in the blister portion of the study (Arm 1) only:
- Viral hepatitis B or C. Test results, including those from an outside facility or lab, within the prior 6 months will be accepted.
- HIV positive. Test results, including those from an outside facility or lab, within the prior 6 months will be accepted.
- Individuals on anticoagulant or anti-platelet therapy (other than aspirin or NSAIDs as described in the protocol).
- Pregnancy.
Exclusion
Key Trial Info
Start Date :
October 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02262819
Start Date
October 10 2014
End Date
April 24 2019
Last Update
March 30 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892