Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02839551
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Doses for Drug Provocation Tests to Beta-lactams
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NewBL
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).
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: