Optimal Doses for Drug Provocation Tests to Beta-lactams

NCT ID: NCT02839551

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2021-11-16

Brief Summary

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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).

Detailed Description

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Conditions

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Drug Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Simplified drug provocation test

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Group Type EXPERIMENTAL

simplified drug provocation test

Intervention Type PROCEDURE

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Interventions

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simplified drug provocation test

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital of Montpellier

Montpellier, France, France

Site Status

Countries

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France

Other Identifiers

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RECHMPL15_0269

Identifier Type: -

Identifier Source: org_study_id

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