Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years (AZITHRO)

June 14, 2016 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2055

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The eligible population consists of patients over 7 years old with CF followed in Resource Centres and Competence for Cystic Fibrosis (CRCM) France.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cystic fibrosis patients taking azithromycin
Cystic fibrosis patients taking azithromycin continuously for two years.
Drug: Azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in one second (FEV1).
Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index (BMI)
Time Frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
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
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
yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Isabelle DURIEU, Pr, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL14_0240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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