Cystic FibrosisAZITHRONCT02803944
Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Azithromycin
- How many people
- 2,055 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, 69310
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Azithromycin
- Keywords
- azithromycin, cystic fibrosis, pulmonary function
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis patients taking azithromycin | Cystic fibrosis patients taking azithromycin continuously for two years. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1).
Measured: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Secondary outcomes (3)
Body Mass Index (BMI)
Measured: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Number of IV antibiotics cures
Measured: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Pseudomonas aeruginosa colonization
Measured: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle DURIEU, Pr, Principal investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803944
- Sponsor's protocol ID
- 69HCL14_0240
- Acronym
- AZITHRO
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database
- ClinicalTrials.gov ID
- NCT02803944
- Acronym / sponsor ID
- AZITHRO / 69HCL14_0240
- Conditions
- Cystic Fibrosis
- Keywords
- azithromycin, cystic fibrosis, pulmonary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,055 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis patients taking azithromycin | – | Drug: AzithromycinCystic fibrosis patients taking azithromycin continuously for two years. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin | Drug | Cystic fibrosis patients taking azithromycin |
Primary outcome
Forced expiratory volume in one second (FEV1).
Time frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
3 secondary outcomes
Body Mass Index (BMI)
Time frame: 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
Pseudomonas aeruginosa colonization
Time frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle DURIEU, Pr principal investigator
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1). (time frame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.