Phase 4 N=284 Randomized Diagnostic

Penicillin Allergy Testing in STD Clinics

Penicillin Allergy

Bottom Line

View on ClinicalTrials.gov: NCT04620746 ↗

Enrolled (actual)

284

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study — 36; 36 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Penicillin Major Determinant (PrePen) Skin Testing (Drug); Direct Oral challenge (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study	36; 36	—
PRIMARY Safety of Direct Oral Challenge Defined by Number of Subjects Who Did Not Have Pre-defined Changes in Vital Signs or Pre-defined Emergence of New Respiratory or Skin Symptoms After Oral Challenge	96; 95	0.98
SECONDARY Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire	99; 89	0.95
SECONDARY Provider Assessment of Feasibility of Allergy Evaluation at the End of Study	11	—

Summary

Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing

Eligibility Criteria

Inclusion Criteria

Prior history of PCN allergy

Exclusion Criteria

No immunodeficiency or contraindication to skin testing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04620746). 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.