CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 284 enrolled
Drug / intervention
Penicillin Major Determinant (PrePen) Skin Testing +1 moredrug
Likely dose
Penicillin Major Determinant (PrePen) Skin Testing 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04620746
NCT04620746Phase 4Completed
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Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients

Johns Hopkins University·interventional·Posted Nov 9, 2020·Updated Sep 21, 2023

In Brief

A Phase 4 clinical trial evaluating Penicillin Major Determinant (PrePen) Skin Testing and Direct Oral challenge for Penicillin Allergy. Completed, enrolled 284 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPenicillin Allergy
CountriesUnited States
CollaboratorsIndiana University, Wake Forest University Health Sciences, Louisiana State University Health Sciences Center in New Orleans, University of Washington

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedNov 9, 2020
Enrollment StartJun 1, 2021
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.6 years ago

Interventions

Penicillin Major Determinant (PrePen) Skin Testingdrug

Skin testing followed by oral challenge with amoxicillin 250 mg single dose

Direct Oral challengedrug

Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose