Optimal Doses for Drug Provocation Tests to Beta-lactams

University Hospital, Montpellier1,252 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,252

Conditions

Drug Hypersensitivity

Interventions

simplified drug provocation testPROCEDURE

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospital of Montpellier

Montpellier, France, France

Outcomes

Primary Outcomes

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

Time frame: up to 1 hour

Data from ClinicalTrials.gov

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