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Optimal Doses for Drug Provocation Tests to Beta-lactams

NCT02839551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1252

Last updated 2025-09-30

No results posted yet for this study

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

PROCEDURE

simplified drug provocation test

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-04
Primary Completion
2021-11-16
Completion
2021-11-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02839551 on ClinicalTrials.gov