Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

Cystic Fibrosis Clinical Trial

— AZITHRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803944
• Other study ID #: 69HCL14_0240
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 14, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2055
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1).		yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin	No
Secondary	Body Mass Index (BMI)		yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin	No
Secondary	Number of IV antibiotics cures		yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin	No
Secondary	Pseudomonas aeruginosa colonization		yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin	Yes