Optimal Doses for Drug Provocation Tests to Beta-lactams

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02839551

Acronym

NewBL

Enrollment

1252

Registered

2016-07-21

Start date

2016-05-04

Completion date

2021-11-16

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

Keywords

Betalactams, Drug hypersensitivity, Drug provocation test, Reactive dose

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).

Interventions

PROCEDUREsimplified drug provocation test

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026