Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Azithromycin

• Registration Number: NCT02803944
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Last Update Submitted: 2016-06-14
• Study First Posted: 2016-06-17
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2055

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystic fibrosis patients taking azithromycin	Azithromycin	Cystic fibrosis patients taking azithromycin continuously for two years.

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second (FEV1).	yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Number of IV antibiotics cures	yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Pseudomonas aeruginosa colonization	yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

Trial Locations

Locations (1)

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet; 🇫🇷 Pierre-Bénite, France