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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.