Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00868842
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 desensitization of peripheral blood basophils. The primary endpoint(s) will be PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium ionophore.

Condition or disease
Anaphylaxis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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 Desensitization of Peripheral Blood Basophils.
Study Start Date : January 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Decreased skin test sensitivity to Pre-pen (PC3 value) [ Time Frame: June 2012 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinical and community recruitment
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868842


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Lawrence B. Schwartz, M.D., Ph.D Virginia Commonwealth University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00868842    
Other Study ID Numbers: HM10870
AADCRC-VCU-01
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014
Keywords provided by Virginia Commonwealth University:
Penicillin
Allergy
Prevention
 Anaphylaxis
Clinically proven history of penicillin allergy
preventing anaphylaxis
Additional relevant MeSH terms:
Layout table for MeSH terms
Anaphylaxis
Shock
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Pathologic Processes