Status:
COMPLETED
Evaluation of Skin Testing Reagents for Penicillin Allergy
Lead Sponsor:
AllerQuest LLC
Conditions:
History of IgE Dependent Reaction to a Penicillin Product
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000, Neugut et al. 20...
Detailed Description
This is a prospective, open-label investigation of skin testing with the Penicillin Skin Test Kit in subjects at least 18 years of age with a self-reported history of possible IgE-dependent penicillin...
Eligibility Criteria
Inclusion
- Subject must have provided written, informed consent prior to performance of any procedures.
- Subject can be male or female and must be generally healthy and at least 18 years of age.
- Subject must have a reported history of possible IgE dependent reaction to a penicillin or its semi-synthetic derivatives, including one or more of the following: anaphylaxis, decreased blood pressure and/or diminished consciousness, upper or lower airway obstruction, angioedema, urticaria, and/or generalized pruritic rash.
Exclusion
- Subject who has exhibited a systemic allergic reaction to previous skin-test administration of PRE-PEN, MDM, or individual penicillin metabolites (benzylpenicillin, benzylpenicilloate, or benzylpenilloate).
- Subject who is pregnant or lactating.
- Subject who has had a respiratory infection within the past 2 weeks or has taken antibiotics of any kind during the past 2 weeks (except for topical antibiotics for acne).
- Subject who has taken an oral H1-antihistamine within 72 hours prior to skin testing.
- Subject who has taken hydroxyzine or doxepin within 7 days prior to skin testing.
- Subject who has had a penicillin reaction, including semisynthetic penicillins, within the last 6 weeks prior to skin testing.
- Subject who has received an investigational drug within 30 days prior to skin testing or who plans to participate in a study in which an investigational drug will be administered within the 30 days following skin testing.
- Subjects who have planned hospitalizations or medical or surgical procedures during the 72 hours following the oral amoxicillin challenge.
- Subjects who plan to take any new prescription or over-the-counter medications or herbal supplements during the 72 hours following the oral amoxicillin challenge.
- Subject who has had a previous adverse reaction to penicillin or semisynthetic derivative and subsequently tolerated a penicillin or semisynthetic derivative without an adverse experience.
- Subject who, in the investigator's opinion, has any other social or medical condition (e.g. fever, rash) that may place the subject at increased risk or may confound the interpretation of the study.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT01818336
Start Date
December 1 2012
End Date
June 1 2013
Last Update
January 4 2017
Active Locations (13)
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1
Alabama Allergy & Asthma Center
Homewood, Alabama, United States, 35209
2
Allergy Associates of Tucson
Tucson, Arizona, United States, 85716
3
Allergy & Asthma Clinical Research
Walnut Creek, California, United States, 94590
4
Fairfield County Allergy, Asthma & Immunology Assoc., Inc.
Norwalk, Connecticut, United States, 06851