Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)

Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003023-22-FR

Enrollment

100

Registered

2015-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchiectasis excluding cystic fibrosis in children

Interventions

Trade Name: ZITHOMAX 40 mg/ml ENFANTS Product Name: zithromax Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: AZITHROMYCIN DIHYDRATE Current Sponsor code: azithromycine Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 3-17 years - Male and female - With bronchiectasis, excluding cystic fibrosis, diagnosed for at least 2 years - Already treated with azithromycin for at least 6 months - Without exacerbation for one month - with social insurance - whose parents or legal guardian have given their written consent Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients whose parents are unable to understand the purpose and conditions of carrying out the study, unable to give their consent - May not be able to participate in the entire study - Including in another clinical trial or in exclusion period of a previous clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate the time of onset of an exacerbation after withdrawal or not of the azithromycin treatment in children with bronchiectasis excluding cystic fibrosis treated with azithromycin for at least 6 months. ;Secondary Objective: - Study the effect of treatment withdrawal on the severity of cough, the respiratory function and the quality of life of patients and their parents - Evaluate the efficacy of the treatment regarding the 4 different causes of bronchiectasis (sequelae of respiratory infections, primary ciliary dyskinesia, immune deficiency, other causes) - Identify the microbial strains present in sputum at the beginning and the end of the study, and to monitor the development of antibiotics resistance ;Primary end point(s): the time of onset of the first exacerbation;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Main Objective: evaluate the time of onset of an exacerbation after withdrawal or not of the azithromycin treatment in children with bronchiectasis excluding cystic fibrosis treated with azithromycin for at least 6 months. ;Secondary Objective: - Study the effect of treatment withdrawal on the severity of cough, the respiratory function and the quality of life of patients and their parents - Evaluate the efficacy of the treatment regarding the 4 different causes of bronchiectasis (sequelae of respiratory infections, primary ciliary dyskinesia, immune deficiency, other causes) - Identify the microbial strains present in sputum at the beginning and the end of the study, and to monitor the development of antibiotics resistance ;Primary end point(s): the time of onset of the first exacerbation;Timepoint(s) of evaluation of this end point: 18 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Cough score with a visual analogue scale (VAS) and a verbal descriptive scale (VDS) (daily monitoring by parents thanks to a diary). - Measure of the respiratory function by spirometry (depending on age of patients) - Scale of quality of life associated with chronic cough (PC-QOL questionnaire, short version) - Scale of general quality of life - Standard bacteriologic analyses and identification of microbial strains by mass spectrometry;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Secondary end point(s): - Cough score with a visual analogue scale (VAS) and a verbal descriptive scale (VDS) (daily monitoring by parents thanks to a diary). - Measure of the respiratory function by spirometry (depending on age of patients) - Scale of quality of life associated with chronic cough (PC-QOL questionnaire, short version) - Scale of general quality of life - Standard bacteriologic analyses and identification of microbial strains by mass spectrometry;Timepoint(s) of evaluation of this end point: 18 months

—

Countries

France

Contacts

Public Contactalexandra GIULIANI

ASSISATNCE PUBLIQUE HOPITAUX DE MARSEILLE

alexandra.giuliani@ap-hm.fr0491382747

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026