Negative Predictive Value of Drug Provocation Tests to Beta-lactams

Drug Hypersensitivity Clinical Trial

— NPVDPT  

Official title:

Negative Predictive Value of Drug Provocation Tests to Beta-lactams

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02844712
• Other study ID #: 9394
• Status: Terminated
• Phase: N/A
• First received: July 15, 2016
• Last updated: July 25, 2016
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 750
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Evaluation of reexposure to a negatively tested betalactam

Locations

Country	Name	City	State
France	Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value of drug provocation tests to betalactams		one day	Yes
Secondary	The types of reactions upon reexposure to a negatively tested betalactam		one day	Yes