NCT02844712

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

July 15, 2016

Last Update Submit

July 25, 2016

Conditions

Drug Hypersensitivity

Keywords

Drug hypersensitivityBetalactamDrug provocation test

Outcome Measures

Primary Outcomes (1)

  • Negative predictive value of drug provocation tests to betalactams

    one day

Secondary Outcomes (1)

  • The types of reactions upon reexposure to a negatively tested betalactam

    one day

Study Arms (1)

Evaluation of reexposure to a negatively tested betalactam

OTHER
Other: Evaluation of reexposure to a negatively tested betalactam

Interventions

Evaluation of reexposure to a negatively tested betalactamOTHER
Evaluation of reexposure to a negatively tested betalactam

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is under judicial protection, guardianship or curatorship
  • The patient or the patient's legal representatives do not read fluently the French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 26, 2016

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

FR(1)