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

University Hospital Center (CHU)

Status: Completed

Conditions: Drug Hypersensitivity

Treatments: Procedure: simplified drug provocation test

Study type: Interventional

Funder types: Other

Identifiers

NCT02839551

9611

Details and patient eligibility

About

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).

Enrollment: 1,252 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,252 participants in 1 patient group

Simplified drug provocation test

Experimental group

Description:

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Treatment:

Procedure: simplified drug provocation test