Negative Predictive Value of Drug Provocation Tests to Beta-lactams (NPVDPT)

July 25, 2016 updated by: University Hospital, Montpellier
Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.

Study Overview

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Not Applicable

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

      • Montpellier, France, 34295
        • Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier

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

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam
  • The patient or the patient's legal representatives are not their opposition to participate in this study
  • The patient must be affiliated or beneficiary in a health insurance system

Exclusion Criteria:

  • The patient is exclusion period determined by a previous study
  • The patient is under judicial protection, guardianship or curatorship
  • The patient or the patient's legal representatives do not read fluently the French language

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Evaluation of reexposure to a negatively tested betalactam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negative predictive value of drug provocation tests to betalactams
Time Frame: one day
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
The types of reactions upon reexposure to a negatively tested betalactam
Time Frame: one day
one day

Collaborators and Investigators

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

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

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

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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