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)

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2014-003023-22-FR
• Date of registration: 22/06/2015
• Prospective Registration: Yes
• Primary sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
• Public title: 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)
• Scientific title: 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
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003023-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: the treatment will be stopped; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: alexandra GIULIANI
• Affiliation: ASSISATNCE PUBLIQUE HOPITAUX DE MARSEILLE

• Name: alexandra GIULIANI
• Affiliation: ASSISATNCE PUBLIQUE HOPITAUX DE MARSEILLE

Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

bronchiectasis excluding cystic fibrosis in children

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 41,92-

Trade Name: ZITHROMAX 250 mg
Product Name: ZITHROMAX
Pharmaceutical Form: Tablet
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Current Sponsor code: azithromycine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 262-

Primary Outcome(s)

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

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.

Primary end point(s): the time of onset of the first exacerbation

Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome(s)

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

Secondary ID(s)

2014-26

Source(s) of Monetary Support

ministère de la sante