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Completed

NCT Number: NCT02803944

Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Azithromycin

Drug

Primary outcomes

  1. 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 outcomes

  1. Body Mass Index (BMI)

    Time frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

  2. Number of IV antibiotics cures

    Time frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

  3. Pseudomonas aeruginosa colonization

    Time frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: AZITHRO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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