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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

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Negative predictive value of drug provocation tests to betalactams [ Time Frame: one day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
The types of reactions upon reexposure to a negatively tested betalactam [ Time Frame: one day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Predictive Value of Drug Provocation Tests to Beta-lactams
Official Title  ICMJE Negative Predictive Value of Drug Provocation Tests to Beta-lactams
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Drug Hypersensitivity
Intervention  ICMJE Other: Evaluation of reexposure to a negatively tested betalactam
Study Arms  ICMJE Evaluation of reexposure to a negatively tested betalactam
Intervention: Other: Evaluation of reexposure to a negatively tested betalactam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
750
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02844712
Other Study ID Numbers  ICMJE 9394
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Montpellier
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP