NCT02839551

Optimal Doses for Drug Provocation Tests to Beta-lactams

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,252 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Drug Hypersensitivity

Interventions

Type	Name	Description
PROCEDURE	simplified drug provocation test	Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Timeline

• Start date: 2016-05-04
• Primary completion: 2021-11-16
• Completion: 2021-11-16
• First posted: 2016-07-21
• Last updated: 2025-09-30

Locations

1 site across 1 country: France