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The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis (AZI-STOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531984
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE August 25, 2015
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
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 ]
Exacerbations are defined by a combination of major and minor clinical criteria (Kapur et al, 2012) and the need for an antibiotic therapy for lower respiratory tract in case of acute infection. These criteria are evaluated by parents with the help of a daily diary; respiratory exacerbation is confirmed by a clinical examination.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis
Official Title  ICMJE 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 )
Brief Summary

Bronchiectasis is characterized by a permanent and abnormal dilatation of a part of the bronchial tree. An accumulation of mucus in the respiratory tract ensues, resulting in frequent bacterial infections and eventual destruction of the lungs. Clinically, patients present with a chronic productive cough and episodes of acute respiratory exacerbations. Chronic respiratory failure can follow. Although its prevalence is largely unknown, bronchiectasis is considered to be a rare and orphan disease. There are numerous causes for this disease: sequelae of respiratory infections, immunodeficiency, genetic diseases like cystic fibrosis, primary ciliary dyskinesia….The focus of this study will be on non cystic fibrosis bronchiectasis in children.

Due to a lack of pediatric clinical trials, the management of children with this disease is widely based on the management of adults or patients with cystic fibrosis or pan-bronchiolitis. The treatment is based on respiratory physiotherapy, prevention of infections, administration of inhaled corticosteroids and anti biotherapy for acute exacerbations.

Recently, some studies have demonstrated the efficacy of a family of antibiotics, the macrolides, in the treatment of cystic fibrosis or pan-bronchiolitis in children. Indeed, taken 3 times a week during a long period of time, the macrolides, and specifically the azithromycin have shown some anti-inflammatory and tissue repairing properties, in addition to their antimicrobial properties.

Moreover, several studies conducted in the adult population have shown that the use of azithromycin has led to significant reduction in the frequency of respiratory exacerbations as well as an improvement in the quality of life.

The efficacy of azithromycin in these respiratory diseases has led to enlarge its use for the long term treatment of bronchiectasis. Yet, this type of treatment has no marketing authorization application.

No studies have been conducted in children, but individual examination of patients with bronchiectasis treated with azithromycin suggests an improvement of their symptoms.

Thus, the use of azithromycin in the treatment of bronchiectasis in children seems to be a promising therapy. However, its efficacy needs to be demonstrated by clinical trials led on a pediatric population with an adequate number of patients and a strong methodology in order to ensure validity and reliability of the results.

Therefore the investigators decided to conduct a comparative, prospective multicenter randomized study in this population.

This study intends to include 100 patients already treated by azithromycin for at least 6 months. After inclusion, they will be randomized in two groups of 50 patients each. The first group will continue the treatment and the other one will discontinue it.

The patients will be followed from the inclusion period (M0) until the onset of the first exacerbation for a maximum of 6 months (M6), with an intermediate health care visit after 3 months (M3).

In case of exacerbation, a health care visit will be scheduled; the patient will receive the appropriate treatment and he will be suspended from the study.

The duration of follow up for each patient is dictated by the occurrence of the first respiratory exacerbation, a maximum of 6 months .The total inclusion period is 12 months and the total duration of the study is 18 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Cystic Fibrosis Bronchiectasis in Children
Intervention  ICMJE Drug: Azithromycin
Study Arms  ICMJE
  • Experimental: Withdrawal of Azithromycin treatment
    Intervention: Drug: Azithromycin
  • ongoing Azithromycin treatment
    Intervention: Drug: Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 24, 2015)
100
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 )
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531984
Other Study ID Numbers  ICMJE 2014-26
RC12_3643 ( Other Identifier: Assistance Publique Hôpitaux de Marseille )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP