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NCT02262819 · ClinicalTrials.gov registry record · Phase 1
Human Immunity Against Staphylococcus Aureus Skin Infection
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02262819 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants.
The verdict
NCT02262819, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
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.
Interventions
- DRUG S. aureus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-10-10 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02262819
The ClinicalTrials.gov registry entry for NCT02262819 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which S. aureus is the first listed.
NCT02262819 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02262819 about?
NCT02262819 is a clinical study titled "Human Immunity Against Staphylococcus Aureus Skin Infection". 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 peo...
What is the current status of trial NCT02262819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2014-10-10. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT02262819?
The interventions under investigation include: S. aureus (DRUG).
Who is sponsoring clinical trial NCT02262819?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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