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

Primary Purpose

Drug Hypersensitivity

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of reexposure to a negatively tested betalactam
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Drug Hypersensitivity focused on measuring Drug hypersensitivity, Betalactam, Drug provocation test

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Evaluation of reexposure to a negatively tested betalactam

Arm Description

Outcomes

Primary Outcome Measures

Negative predictive value of drug provocation tests to betalactams

Secondary Outcome Measures

The types of reactions upon reexposure to a negatively tested betalactam

Full Information

First Posted
July 15, 2016
Last Updated
July 25, 2016
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02844712
Brief Title
Negative Predictive Value of Drug Provocation Tests to Beta-lactams
Acronym
NPVDPT
Official Title
Negative Predictive Value of Drug Provocation Tests to Beta-lactams
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
End of the period of inclusion, NSN not achieved
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Hypersensitivity
Keywords
Drug hypersensitivity, Betalactam, Drug provocation test

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of reexposure to a negatively tested betalactam
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Evaluation of reexposure to a negatively tested betalactam
Primary Outcome Measure Information:
Title
Negative predictive value of drug provocation tests to betalactams
Time Frame
one day
Secondary Outcome Measure Information:
Title
The types of reactions upon reexposure to a negatively tested betalactam
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

Negative Predictive Value of Drug Provocation Tests to Beta-lactams

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