Phase 3
N=450
Evaluation of Skin Testing Reagents for Penicillin Allergy
History of IgE Dependent Reaction to a Penicillin Product
Bottom Line
View on ClinicalTrials.gov: NCT01818336 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Negative Predictive Value — 98.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Penicillin skin test kit (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AllerQuest LLC
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Predictive Value |
98.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01818336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.