Optimal Doses for Drug Provocation Tests to Beta-lactams
- Conditions
- Drug Hypersensitivity
- Interventions
- Procedure: simplified drug provocation test
- Registration Number
- NCT02839551
- Lead Sponsor
- University Hospital, Montpellier
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1252
- patients with positive Drug Provocation Test (DPT) to beta-lactams
- contra-indications to DPT
- refusal of participation
- vulnerable patients according to French regulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Simplified drug provocation test simplified drug provocation test Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
- Primary Outcome Measures
Name Time Method Assessment of the new simplified drug provocation test up to 1 hour Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University hospital of Montpellier
🇫🇷Montpellier, France