Evaluation of Skin Testing Reagents for Penicillin Allergy
Information source: AllerQuest LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: History of IgE Dependent Reaction to a Penicillin Product
Intervention: Penicillin skin test kit (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AllerQuest LLC Official(s) and/or principal investigator(s): N. Franklin Adkinson, Jr., MD, Study Director, Affiliation: AllerQuest LLC
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. 2001). Yet approximately 80% of patients labeled as allergic to the
penicillins can safely take these antibiotics without fear of a life-threatening reaction
(Gadde et al. 1993, Macy et al. 1997). The outcomes of this erroneous classification of
patients include unnecessary denial of an effective and well-tolerated class of antibiotics,
which are often the treatment of choice.
The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at
very low risk of developing acute IgE-dependent reactions when given a penicillin or
cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral
challenge with a penicillin.
Clinical Details
Official title: Confirmatory Study to Examine Negative Predictive Value (NPV) and Safety of Skin Testing With PRE-PEN, a Minor Determinant MIxture (MDM) of Penicillin Antigens, and Amoxicillin Reagent Against an Oral Challenge With Amoxicillin
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Utility of NPV
Secondary outcome: Safety Endpoints
Detailed description:
This is a prospective, open-label investigation of skin testing with the Penicillin Skin
Test Kit in subjects at least 2 years of age with a self-reported history of possible
IgE-dependent penicillin hypersensitivity.
At screening on Day 1, subjects and their parents/legal guardians (if applicable) will sign
the informed consent form/ pediatric assent form. Following consent/assent, demographic
information and medical history will be obtained, including prior and current medication
use. Subjects will also be asked if they have had a respiratory infection in the past 2
weeks or antibiotics within the past 4 weeks. A physical examination will be performed,
along with measurements of vital signs and, in subjects >5 years of age with active asthma,
peak expiratory flow rate (PEFR). A urine pregnancy test will be obtained for all female
subjects of childbearing potential.
The skin test procedure will first involve puncture testing. Skin test reagents will include
the Penicillin Skin Test Kit, histamine (positive control), and sodium chloride (negative
control). Subjects who have negative skin puncture test results to any of the drug antigens
contained within the Penicillin Skin Test Kit will then undergo intradermal testing in
duplicate. Subjects who have a positive reaction to one or more puncture or intradermal
tests contained within the Penicillin Skin Test Kit will be discharged from the study.
However, subjects with any positive skin test to drug antigens in the Penicillin Skin Test
Kit will be asked to return for retesting (puncture and intradermal) in 4 weeks.
Subjects who have negative puncture and intradermal test results will be given the oral
amoxicillin challenge, which will be comprised of a single, full oral dose of amoxicillin.
The purpose of the oral amoxicillin challenge is to confirm lack of allergy and confirm the
NPV (Negative Predictive Value) of skin testing. Subjects will be monitored at the study
site for 1 hour following oral amoxicillin challenge and then sent home. The study site will
follow-up by telephone with all subjects (or their parents/legal guardians in the case of
young children) ≥72 hours after administration of the oral amoxicillin challenge.
Adverse events (AEs) will be recorded from administration of the Penicillin Skin Test
throughout the 3-day study period as spontaneously reported by subjects or observed by the
site staff.
Two normal subjects (i. e., no history of penicillin allergy) will be skin tested at each
site to provide data on skin test specificity.
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subject (and/or parent or legal guardian for subjects <18 years of age) must have
provided written, informed consent prior to performance of any procedures. Children
6-11 years of age must provide verbal assent (or written assent, if required by local
regulations), and children 12-17 years of age must provide written informed consent
along with their parent or legal guardian.
2. Subject can be male or female and must be generally healthy and at least two (2)
years of age.
3. 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 Criteria:
- 1. 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).
2. Subject who is pregnant or lactating. 3. 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).
4. Subject who has taken an oral H1-antihistamine within 72 hours prior to skin
testing.
5. Subject who has taken hydroxyzine or doxepin within 7 days prior to skin testing.
6. Subject who has had a penicillin reaction, including semisynthetic penicillins,
within the last 6 weeks prior to skin testing.
7. 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.
8. Subjects who have planned hospitalizations or medical or surgical procedures
during the 72 hours following the oral amoxicillin challenge.
9. 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.
10. 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.
11. 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.
Locations and Contacts
Alabama Allergy & Asthma Center, Homewood, Alabama 35209, United States
Allergy Associates of Tucson, Tucson, Arizona 85716, United States
Allergy & Asthma Clinical Research, Walnut Creek, California 94590, United States
Fairfield County Allergy, Asthma & Immunology Assoc., Inc., Norwalk, Connecticut 06851, United States
Ct. Asthma & Allergy Center LLC, West Hartford, Connecticut 06119, United States
Windom Allergy, Sarasota, Florida 34233, United States
Atlanta Allergy and Asthma Clinic, Atlanta, Georgia 30060, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
Washington University Medical School, St. Louis, Missouri 63110, United States
Midwest Allergy & Asthma Clinic PC, Omaha, Nebraska 68130, United States
Corvallis Clinic, Corvallis, Oregon 97330, United States
Allergy & Asthma Care, Germantown, Tennessee 38138, United States
Northwest Asthma & Allergy Center, Redmond, Washington 98052, United States
Additional Information
Starting date: December 2012
Last updated: September 10, 2013
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