Clinical Trial: Optimal Doses for Drug Provocation Tests to Beta-lactams

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: University Hospital, Montpellier

Current Primary Outcome: Assessment of the new simplified drug provocation test [ Time Frame: up to 1 hour ]

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


Original Primary Outcome: Assessment of the new simplifed drug provocation test [ Time Frame: up to 1 hour ]

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


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Montpellier

Dates:
Date Received: July 18, 2016
Date Started: May 2016
Date Completion: March 2018
Last Updated: July 21, 2016
Last Verified: July 2016