Negative Predictive Value of Drug Provocation Tests to Be... | NCT02844712

Studies
Negative Predictive Value of Drug Provocation Tests to Beta-lactams

NCT02844712

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Jul 26, 2016Estimated

Enrollment

750Actual

Phase

Not Applicable

Conditions

Drug Hypersensitivity

Interventions

Evaluation of reexposure to a negatively tested betalactam

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

End of the period of inclusion, NSN not achieved

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

May 2016Actual

Completion Date

Nov 2016Estimated

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Jul 25, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

750Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evaluation of reexposure to a negatively tested betalactam	Other		Other: Evaluation of reexposure to a negatively tested betalactam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evaluation of reexposure to a negatively tested betalactam	Other		Evaluation of reexposure to a negatively tested betalactam

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D004342	Drug Hypersensitivity

Ancestor Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided