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Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02803944
Acronym
AZITHRO
Enrollment
2055
Registered
2016-06-17
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

azithromycin, cystic fibrosis, pulmonary function

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.

Interventions

DRUGAzithromycin

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

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

Secondary

MeasureTime frame
Body Mass Index (BMI)yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Number of IV antibiotics curesyearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Pseudomonas aeruginosa colonizationyearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026