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Trial record 3 of 64 for:    Recruiting, Not yet recruiting, Available Studies | Drug allergy

Optimal Doses for Drug Provocation Tests to Beta-lactams (NewBL)

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ClinicalTrials.gov Identifier: NCT02839551
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Drug Hypersensitivity Procedure: simplified drug provocation test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
Actual Study Start Date : May 4, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Simplified drug provocation test
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
Procedure: simplified drug provocation test
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839551


Locations
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France
University hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Pascal Demoly, MD,PhD       pascal.demoly@inserm.fr   
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02839551     History of Changes
Other Study ID Numbers: 9611
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
Betalactams
Drug hypersensitivity
Drug provocation test
Reactive dose
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents