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Skin Testing Arm for Penicillin Allergy

Phase 4

Waitlist Available

Led By Jonathan M Zenilman

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior history of PCN allergy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial will help to determine whether penicillin allergy testing can be used to safely treat STD patients.

Eligible Conditions

Penicillin Allergy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study

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

Secondary outcome measures

Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire

Provider Assessment of Feasibility of Allergy Evaluation at the End of Study

Trial Design

2Treatment groups

Active Control

Group I: Skin Testing ArmActive Control2 Interventions

These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge

Group II: Direct Oral ChallengeActive Control1 Intervention

These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,482 Total Patients Enrolled

Louisiana State University Health Sciences Center in New OrleansOTHER

114 Previous Clinical Trials

43,917 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers is this experiment operating in?

"Currently, 4 clinical sites are looking to enroll patients for this trial. Potential participants can choose from New Orleans, Indianapolis and Seattle as well as four additional locations nearby. To decrease the amount of travel necessary, it is prudent to select a site that is proximate to your current home."

Answered by AI

What ailments is Skin Testing Arm most commonly prescribed for?

"Skin Testing Arm is typically administered to treat gram-negative bacterial infections. Additionally, it can help with persistent facial erythema, rhinorrhoea, and nasal intubation issues."

Answered by AI

Is this research opportunity available to participants currently?

"Affirmative. Clinicaltrials.gov hosts the data which proves that this clinical trial, first posted on June 1st 2021, is actively recruiting volunteers. Around a thousand participants need to be found from 4 distinct medical facilities."

Answered by AI

What is the maximum capacity for this research study's participation?

"This clinical trial necessitates 1000 participants who fulfill the pre-defined requirements. Potential volunteers can join from two locations, namely Louisiana State University's medical centre in New Orleans and Indiana University's facility in Indianapolis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Penicillin Allergy Testing in STD Clinics

2021. "Penicillin Allergy Testing in STD Clinics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04620746.