Outcome of Patients After a Negative Oral Challenge to Amoxicillin (REINAD)

September 21, 2023 updated by: University Hospital, Angers

Study of Patient's Outcomes After a Negative Reintroduction Test for Amoxicillin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed 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 to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Maine Et Loire
      • Angers, Maine Et Loire, France, 49933
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resumption of Amoxicillin after a negative oral challenge to Amoxicillin
Time Frame: Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Actual)

July 18, 2022

Study Completion (Actual)

July 18, 2022

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC21_0178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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