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Penicillin Allergy Testing in STD Clinics

NCT04620746 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2023-09-21

Study results available
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Summary

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

Conditions

  • Penicillin Allergy

Interventions

DRUG

Penicillin Major Determinant (PrePen) Skin Testing

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

DRUG

Direct Oral challenge

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

Sponsors & Collaborators

  • Indiana University School of Medicine

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Jonathan M Zenilman · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620746 on ClinicalTrials.gov