NCT04620746

Penicillin Allergy Testing in STD Clinics

Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge

Conditions

• Penicillin Allergy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-11-09
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study