Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

NCT02803944 | Completed

• 1 other identifier: 69HCL14_0240
• Study Type: observational
• Target: 2,055
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

azithromycin; cystic fibrosis; pulmonary function

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in one second (FEV1).

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

Secondary Outcomes (3)

• 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

Study Arms (1)

Cystic fibrosis patients taking azithromycin

Cystic fibrosis patients taking azithromycin continuously for two years.

Drug: Azithromycin

Interventions

Azithromycin DRUG

Cystic fibrosis patients taking azithromycin

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Isabelle DURIEU, Pr

  Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

FR (1)