Human Immunity Against Staphylococcus Aureus Skin Infection

• Status: Completed
• Trial end date: 2019-04-24
• Target enrollment: 0
• Participant gender: All

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 treatment. These staph infections can be serious and even deadly. Researchers want to find out why some people are more likely to get the infection.

Objectives:

• To look at the immune response of the skin when it is exposed to bacteria.

Eligibility:

• People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph infections.

• Healthy volunteers.

Design:

• Participants will be screened with medical history, physical exam, and blood tests.

• Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may have additional tests if needed. If they had a recent biopsy, researchers may ask for a sample from it.

• Some participants will spend the night at the clinic. Their vital signs will be taken and they will have blood drawn. Some participants will take aspirin or ibuprofen starting 2 days before their stay.

• Some participants will have blisters created on the inside of their forearm. Suction will pull a layer of skin from their arm. Skin will be removed. Different solutions will be applied to the blisters. Up to 3 biopsies may be taken.

• Children will not have blood tests or biopsies.

• Participants will be called every day for 10 days, then at 30 days after the procedure.

• Participants will have a follow-up visit 10 days after the procedure.

• Participants who did not get blisters or biopsies will not have any follow-up appointments.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

• INCLUSION CRITERIA:

Participants must either:

1. 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

2. 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.