Status:
COMPLETED
Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Anaphylaxis
Eligibility:
All Genders
18-45 years
Brief Summary
This is an open-label, single-center study of whether oral penicillin desensitization of healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin testing and desensit...
Eligibility Criteria
Inclusion
- Written informed consent obtained.
- Male, or non-pregnant female, 18-45 years of age who are in good health.
- Clinical history of a penicillin allergy consisting of an immediate hyper- sensitivity reaction such as anaphylaxis, urticaria/angioedema or broncho- spasm, and a positive skin prick test to penicillin G.
- Positive skin test to at least one aeroallergen to indicate sensitivity, but clinical disease (allergic rhinitis) is not necessary.
Exclusion
- Dermatographism or severe dermatologic condition, such as advanced eczema or psoriasis, that will not allow an adequate uninvolved area for skin testing.
- Negative skin tests to penicillin G or to all aeroallergens test.
- Pregnancy.
- Antihistamine medications taken within one week of testing; systemic steroids, B-blockers or ACE -inhibitors taken over the previous month; omalizumab therapy at any time; those receiving or who have received immunotherapy; and those who have been desensitized to any drug within 6 months.
- Allergic reaction to a B-lactam antibiotic within 1 month.
- Current asthma; significant pulmonary, cardiovascular, renal, hepatobiliary or neurological diseases, or another disease process that the investigator feel would put the subject at risk of an adverse event.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Inability or unwillingness of a participant to give written informed consent.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00868842
Start Date
January 1 2009
End Date
June 1 2012
Last Update
April 14 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298