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

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ClinicalTrials.gov Identifier: NCT02803944
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Cystic Fibrosis Drug: Azithromycin

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Study Type : Observational
Actual Enrollment : 2055 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803944


Locations
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France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Isabelle DURIEU, Pr Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02803944     History of Changes
Other Study ID Numbers: 69HCL14_0240
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Keywords provided by Hospices Civils de Lyon:
azithromycin
cystic fibrosis
pulmonary function
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases