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Completed

NCT Number: NCT02839551

Optimal Doses for Drug Provocation Tests to Beta-lactams

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).

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Key information

Conditions

Drug Hypersensitivity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Montpellier

Montpellier, France, 34295

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simplified drug provocation test

Procedure

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: NewBL

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2016
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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