- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844712
Negative Predictive Value of Drug Provocation Tests to Beta-lactams (NPVDPT)
July 25, 2016 updated by: University Hospital, Montpellier
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
750
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Evaluation of reexposure to a negatively tested betalactam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Negative predictive value of drug provocation tests to betalactams
Time Frame: one day
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The types of reactions upon reexposure to a negatively tested betalactam
Time Frame: one day
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Anticipated)
November 1, 2016
Study Registration Dates
First Submitted
July 15, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimate)
July 26, 2016
Study Record Updates
Last Update Posted (Estimate)
July 26, 2016
Last Update Submitted That Met QC Criteria
July 25, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9394
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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