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Trial record 6 of 257 for:    test AND provocation

Negative Predictive Value of Drug Provocation Tests to Beta-lactams (NPVDPT)

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ClinicalTrials.gov Identifier: NCT02844712
Recruitment Status : Terminated (End of the period of inclusion, NSN not achieved)
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.

Condition or disease Intervention/treatment Phase
Drug Hypersensitivity Other: Evaluation of reexposure to a negatively tested betalactam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Negative Predictive Value of Drug Provocation Tests to Beta-lactams
Study Start Date : December 2014
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Evaluation of reexposure to a negatively tested betalactam Other: Evaluation of reexposure to a negatively tested betalactam



Primary Outcome Measures :
  1. Negative predictive value of drug provocation tests to betalactams [ Time Frame: one day ]

Secondary Outcome Measures :
  1. The types of reactions upon reexposure to a negatively tested betalactam [ Time Frame: one day ]


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam
  • The patient or the patient's legal representatives are not their opposition to participate in this study
  • The patient must be affiliated or beneficiary in a health insurance system

Exclusion Criteria:

  • The patient is exclusion period determined by a previous study
  • The patient is under judicial protection, guardianship or curatorship
  • The patient or the patient's legal representatives do not read fluently the French language

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): NCT02844712


Locations
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France
Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02844712     History of Changes
Other Study ID Numbers: 9394
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Montpellier:
Drug hypersensitivity
Betalactam
Drug provocation test
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