Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT03404804
Eligibility Criteria:
Inclusion Criteria:
* Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.
* Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.
Exclusion Criteria:
* Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
* Any contraindication to allergy testing will also result in exclusion
* (i.e. history of a severe allergic reaction to skin tests,,
* anaphylaxis in the past six weeks,
* known pregnancy
* child has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops).
* Children who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge.
* Patients deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study.
* During this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population.
* Children who are wards of the state, in foster care or police custody or detention will be excluded.
* Children with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned exclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT03404804
Study Brief:
Protocol Section:
NCT03404804