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Human Immunity Against Staphylococcus Aureus Skin Infection

NCT02262819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-03-30

No results posted yet for this study

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.

Conditions

  • Staphylococcus Aureus Skin Infection

Interventions

DRUG

S. aureus

S. aureus, commensal coagulase-negative staphylococcal species, and Gram-negative commensals, such as Roseomonas and Pseudomonas species

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ian A Myles, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-10
Primary Completion
2019-04-24
Completion
2019-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02262819 on ClinicalTrials.gov