The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2015
• Main ID: NCT02531984
• Date of registration: 21/08/2015
• Prospective Registration: No
• Primary sponsor: Assistance Publique Hopitaux De Marseille
• Public title: The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis AZI-STOP
• Scientific title: Open Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study )
• Date of first enrolment: August 2015
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02531984
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: Urielle DESALBRES
• Affiliation: Assistance Publique Hôpitaux de Marseille

Key inclusion & exclusion criteria

Inclusion Criteria:

- Presenting with non cystic fibrosis bronchiectasis documented by chest CT scan ,
diagnosed since at least 2 years

- Already treated with azithromycin for at least 6 months

- Presented no respiratory exacerbation since one month

- Benefit from health insurance

- Have signed a consent (if appropriate age )

- Parents or legal guardian have given their written consent

Exclusion Criteria:

- Patients presenting a history of allergic reaction to azithromycin, érythromycine,
another macrolide or Ketolide or an excipient of Zithromax

- Patients treated with dihydroergotamine or ergotamine , cisapride, colchicine

- Patients presenting severe hepatic failure

- Patients who are unlikely to adhere to the protocol and hence participate in the
entire study ( as judged by the investigator )

- Patients who have not signed the protocol

- Patients whose parents are unable to understand the purpose and conditions of the
study or are unable to give their consent.

- Patients already included in another clinical trial or are in an exclusion period
from a previous clinical trial

- Patients whose ECG shows a QTc > 450 msec ( Zithromax is contraindicated )



Age minimum: 3 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Non Cystic Fibrosis Bronchiectasis in Children

Intervention(s)

Drug: Azithromycin

Primary Outcome(s)

Time of onset of the first respiratory exacerbation in the two groups of patients: those who continued treatment with azithromycin and those who stopped the treatment [Time Frame: 6 months]

Secondary ID(s)

2014-26

RC12_3643

Source(s) of Monetary Support

Please refer to primary and secondary sponsors