Evaluation of Skin Testing Reagents for Penicillin Allergy
Condition: History of IgE Dependent Reaction to a Penicillin Product
Intervention: Penicillin skin test kit
Intervention description: Allergy skin testing is done by puncture and intradermal. If all tests negative, subjects receive an oral amoxicillin challenge.
Intervention MeSH terms: Amoxicillin; Penicillins; Penicillin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: penicillin allergy

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:

          1. Subject must have provided written, informed consent prior to performance of any
             procedures.

          2. Subject can be male or female and must be generally healthy and at least 18 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.