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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 June 2016 |
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Main ID: |
NCT02803944 |
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Date of registration:
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14/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years
AZITHRO |
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Scientific title:
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Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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2055 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02803944 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Isabelle DURIEU, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon - Centre Hospitalier Lyon Sud |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with Cystic Fibrosis (whatever the genetic form)
- Age = 8 years
- FEV = 30% the year of azithromycin (N0)
- Continuous treatment with azithromycin for at least 2 years.
Exclusion Criteria:
Age minimum:
7 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Azithromycin
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Primary Outcome(s)
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Forced expiratory volume in one second (FEV1).
[Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin]
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Secondary Outcome(s)
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Number of IV antibiotics cures
[Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin]
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Body Mass Index (BMI)
[Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin]
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Pseudomonas aeruginosa colonization
[Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin]
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Secondary ID(s)
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69HCL14_0240
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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