Optimal Doses for Drug Provocation Tests to Beta-lactams (NewBL)

December 30, 2021 updated by: University Hospital, Montpellier

Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity

Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.

investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1252

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

  • France
      • Montpellier, France, 34295
        • 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients with positive Drug Provocation Test (DPT) to beta-lactams

Exclusion Criteria:

  • contra-indications to DPT
  • refusal of participation
  • vulnerable patients according to French regulation

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simplified drug provocation test
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
Procedure: simplified drug provocation test
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the new simplified drug provocation test
Time Frame: up to 1 hour
Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test
up to 1 hour

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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 (ACTUAL)

May 4, 2016

Primary Completion (ACTUAL)

November 16, 2021

Study Completion (ACTUAL)

November 16, 2021

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (ESTIMATE)

July 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Drug Hypersensitivity

Clinical Trials on simplified drug provocation test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe