Outcome of Patients After a Negative Oral Challenge to Amoxicillin

NCT04922034 | Completed

• 1 other identifier: 49RC21_0178
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin

Conditions

Negative Challenge to Amoxicillin

Keywords

penicillins; reintroduction

Outcome Measures

Primary Outcomes (1)

• Resumption of Amoxicillin after a negative oral challenge to Amoxicillin

  The main objective is to know if patients who had a negative test for reintroduction of Amoxicillin, have resumed this molecule afterwards.

  Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call

Interventions

Amoxicillin DRUG

Outcome of patients with negative oral challenge to amoxicillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective, single-center, non-interventionnel study of patients with a negative oral challenge to Amoxicillin at Angers University Hospital between 2017 and 2019. An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone one month after the information letter is sent, to answer the questionnaire. This questionnaire, filled in during the telephone interview, concerns the resumption or not of penicillins since the reintroduction test. This study concerns all patients, agreeing to participate in this study, who had a negative challenge test to Amoxicillin at the CHU of Angers from 2017 to 2019. The potential inclusion is approximately 200 individuals.

You may qualify if:

• Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019.
• Major patients.

You may not qualify if:

• Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire
• Person objecting to participate in this research and to the processing of their medical data

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU

Angers, Maine Et Loire, 49933, France

Location

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: January 13, 2022
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: September 22, 2023

Record last verified: 2021-06

Locations

FR (1)