Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years
Overview
Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients. It was shown that this treatment taken every day or every week for 12 months, can improve the respiratory state of patients. From the second year of treatment, it would appear there is more profit to continue such treatment. The main objective is to study the association between continuous use of azithromycin and lung function measured by Forced expiratory volume in one second (FEV1), after two years of treatment.
Full Title of Study: “Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: September 2015
Interventions
- Drug: Azithromycin
Arms, Groups and Cohorts
- Cystic fibrosis patients taking azithromycin
- Cystic fibrosis patients taking azithromycin continuously for two years.
Clinical Trial Outcome Measures
Primary Measures
- Forced expiratory volume in one second (FEV1).
- Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Secondary Measures
- Body Mass Index (BMI)
- Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
- Number of IV antibiotics cures
- Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
- Pseudomonas aeruginosa colonization
- Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Participating in This Clinical Trial
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:
-
Gender Eligibility: All
Minimum Age: 7 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hospices Civils de Lyon
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Isabelle DURIEU, Pr, Principal Investigator, Hospices Civils de Lyon – Centre Hospitalier Lyon Sud
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