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

Primary Purpose

Drug Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
simplified drug provocation test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Drug Hypersensitivity focused on measuring Betalactams, Drug hypersensitivity, Drug provocation test, Reactive dose

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital of Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simplified drug provocation test

Arm Description

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Outcomes

Primary Outcome Measures

Assessment of the new simplified drug provocation test
Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test

Secondary Outcome Measures

Full Information

First Posted
July 18, 2016
Last Updated
December 30, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02839551
Brief Title
Optimal Doses for Drug Provocation Tests to Beta-lactams
Acronym
NewBL
Official Title
Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2016 (Actual)
Primary Completion Date
November 16, 2021 (Actual)
Study Completion Date
November 16, 2021 (Actual)

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
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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simplified drug provocation test
Arm Type
Experimental
Arm Description
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
Intervention Type
Procedure
Intervention Name(s)
simplified drug provocation test
Intervention Description
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
Primary Outcome Measure Information:
Title
Assessment of the new simplified drug provocation test
Description
Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test
Time Frame
up to 1 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Optimal Doses for Drug Provocation Tests to Beta-lactams

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