Phase 4
Completed N=284
Penicillin Allergy Testing in STD Clinics
Penicillin Allergy
Source: ClinicalTrials.gov NCT04620746 ↗
Enrolled (actual)
284
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study — 36; 36 Participants
◆ Published Evidence
Emerging
8citations · ~4 / year
Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients.
Summary
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
Linked Publications
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Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients.
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 | — |
Eligibility Criteria
Inclusion Criteria
- Prior history of PCN allergy
Exclusion Criteria
- No immunodeficiency or contraindication to skin testing
Data sourced from ClinicalTrials.gov (NCT04620746) and the linked publication. 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. Informational only — not medical advice.