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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Antibiotics for bronchiectasis exacerbations in children - The Bronchiectasis Exacerbation Study (Study 1).
Scientific title
A randomised, double blind, placebo controlled trial of Azithromycin versus Amoxycillin-Clavulanic Acid to treat mild to moderate respiratory exacerbations in children with non-Cystic Fibrosis bronchiectasis, Study One.
Secondary ID [1] 273613 0
Universal Trial Number (UTN)
Trial acronym
BEST - 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 285410 0
Condition category
Condition code
Respiratory 285590 285590 0 0
Other respiratory disorders / diseases

Study type
Description of intervention(s) / exposure
Arm 1: Daily oral Azithromycin 5mg/kg for 14 days
Arm 2: Twice daily oral Amoxycillin-Clavulanic Acid 22.5mg/kg for 14 days
Arm 3: oral placebo for 14 days

These treatments are administered at the onset of respiratory exacerbation symptoms after enrolment, and are continued for one exacerbation only.
Intervention code [1] 283899 0
Treatment: Drugs
Comparator / control treatment
Arm 1 recieves ACTIVE azithromycin and PLACEBO amoxycillin-clavulanic acid

Arm 2 receives PLACEBO azithromycin and ACTIVE amoxycillin-clavulanic acid

Arm 3 recieves PLACEBO azithromycin and PLACEBO amoxycillin-clavulanic acid
Control group

Primary outcome [1] 286156 0
The proportion of children with resolution of the respiratory exacerbation (defined by return to baseline state of signs and symptoms). Baseline state is determined by physician assessment at time of study enrolment, and consists of assessment of patient's cough, sputum color, and chest sounds.
Timepoint [1] 286156 0
14 days after initiation of treatment (Azithromycin OR Amoxycillin-Clavulanic acid OR Placebo).
Secondary outcome [1] 295284 0
Detectable difference in PC-QOL (Parent Cough-specific Quality of Life) measurement (minimum important difference between groups =0.9). This is a validated quality of life measure specific to pediatric cough, completed by the parent.
Timepoint [1] 295284 0
Day 14.
Secondary outcome [2] 295285 0
Time of onset to next respiratory exacerbation, assessed by monthly parent follow up calls and 3-monthly clinical assessment by respiratory physician.
Timepoint [2] 295285 0
Measured from resolution of respiratory exacerbation until onset of next exacerbation (measured for up to 6 months after resolution of prior exacerbation).
Secondary outcome [3] 295286 0
Duration of exacerbation symptoms, assessed by parental recording of cough and sputum production.
Timepoint [3] 295286 0
Measured from onset of symptoms of respiratory exacerbation until resolution of symptoms (return to baseline state, see primary outcome above for determination of baseline state).
Secondary outcome [4] 295287 0
Requirement for hospitalisation for respiratory exacerbations.
Timepoint [4] 295287 0
Measured at time of hospitalisation (if applicable) or resolution of symptoms. Measured from enrolment for up to 18 months.
Secondary outcome [5] 295290 0
Detectable difference in serum laboratory assays: CRP, serum amyloid a, IL-6, IL-10, IP-10 (Only done when possible i.e not all children will have bloods taken).
Timepoint [5] 295290 0
Measured at baseline, and start and end of respiratory exacerbations. Total duration is from enrolment for up to 18 months.

Key inclusion criteria
Aged less than 18 years.
Bronchiectasis, as defined by HRCT scan within the last 5-years OR followed by a respiratory physician for treatment of bronchiectasis if diagnosed earlier.
2 or more respiratory exacerbations of bronchiectasis symptoms in the 18 months prior to study enrolment.
Minimum age
No limit
Maximum age
19 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Cystic Fibrosis (defined as measurement of sweat chloride >35mmol/L or by gene mutation). Liver dysfunction. Severe (hypoxic, dyspnoea or hospitalisation required) or recent exacerbation (in the 4 weeks prior to study enrolment). Known hypersensitivity to penicillins or macrolides. Taking regular maintenance antibiotics of the same class as the investigational antibiotics (macrolides and penicillins), or has taken macrolides or penicillins in the 3 weeks prior to study enrolment. Current or recent (within 4 months prior to study enrolment) identification of pseudomonas organism in the airways.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequential allocation list with each next position concealed by opaque covering.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design, stratified by study site, age and aetiology of condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4781 0
Recruitment postcode(s) [2] 4783 0
Recruitment postcode(s) [3] 4785 0
Recruitment postcode(s) [4] 22672 0
6000 - Perth
Recruitment outside Australia
Country [1] 4022 0
New Zealand
State/province [1] 4022 0

Funding & Sponsors
Funding source category [1] 284391 0
Government body
Name [1] 284391 0
National Health and Medical Research Council
Address [1] 284391 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 284391 0
Primary sponsor type
Other Collaborative groups
Qld Children's Medical Research Institute
Queensland Children's Health Service
(Lady Cilento Children's Hospital), Stanley Street, South Brisbane, Qld 4101
Secondary sponsor category [1] 283320 0
Other Collaborative groups
Name [1] 283320 0
Menzies School of Health Research
Address [1] 283320 0
Building 58,
Royal Darwin Hospital
Tiwi, NT 0811
Country [1] 283320 0
Other collaborator category [1] 260397 0
Name [1] 260397 0
Address [1] 260397 0
Flemington Rd
VIC 3052
Country [1] 260397 0
Other collaborator category [2] 260398 0
Name [2] 260398 0
The Children's Hospital at Westmead
Address [2] 260398 0
Cnr Hawkesbury and Hainsworth St
Westmead, NSW 2145
Country [2] 260398 0
Other collaborator category [3] 260399 0
Name [3] 260399 0
The Princess Margaret Hospital for Children
Address [3] 260399 0
Roberts Rd
WA 6008
Country [3] 260399 0
Other collaborator category [4] 260771 0
Name [4] 260771 0
Starship Children's Hospital
Address [4] 260771 0
Park Road, Auckland
Private Bag 92024
Auckland 1142
Country [4] 260771 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 286367 0
Children's Health Services Human Research Ethics Committee (EC00175)
Ethics committee address [1] 286367 0
Children's Health Services (Lady CIlento Children's Hospital), Stanley Street, South Brisbane, QLD 4101
Ethics committee country [1] 286367 0
Date submitted for ethics approval [1] 286367 0
Approval date [1] 286367 0
Ethics approval number [1] 286367 0
Ethics committee name [2] 286368 0
Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research (EC00153)
Ethics committee address [2] 286368 0
John Matthew Building (Building 58),
Royal Darwin Hospital Campus,
PO Box 41096,
Casuarina NT 0811.
Ethics committee country [2] 286368 0
Date submitted for ethics approval [2] 286368 0
Approval date [2] 286368 0
Ethics approval number [2] 286368 0
Ethics committee name [3] 286369 0
Princess Margaret Hospital for Children Ethics Committee (EC00268)
Ethics committee address [3] 286369 0
Ethics Committee, Level 1
Princess Margaret Hospital for Children
GPO Box D184
Perth WA 6840
Ethics committee country [3] 286369 0
Date submitted for ethics approval [3] 286369 0
Approval date [3] 286369 0
Ethics approval number [3] 286369 0
Ethics committee name [4] 286370 0
Sydney Children's Hospitals Network Human Research Ethics Committee (EC00130)
Ethics committee address [4] 286370 0
The Research Ethics Manager
The Research Office
Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [4] 286370 0
Date submitted for ethics approval [4] 286370 0
Approval date [4] 286370 0
Ethics approval number [4] 286370 0
Ethics committee name [5] 286371 0
The University of Queensland Medical Research Ethics Committee (EC00179)
Ethics committee address [5] 286371 0
Ethics Officer
Research & Innovation Division
Cumbrae-Stewart Building (72)
Ethics committee country [5] 286371 0
Date submitted for ethics approval [5] 286371 0
Approval date [5] 286371 0
Ethics approval number [5] 286371 0
Ethics committee name [6] 287166 0
Northern X Health and Disability Ethics Committee
Ethics committee address [6] 287166 0
Ministry of Health,
Private Bag 92-552
Wellesley St
Ethics committee country [6] 287166 0
New Zealand
Date submitted for ethics approval [6] 287166 0
Approval date [6] 287166 0
Ethics approval number [6] 287166 0

Brief summary
Our national study aims to improve the management of acute exacerbations of bronchiectasis in children, a lung condition that is common in Indigenous people worldwide, and also occurs in non-Indigenous people. This study aims to discover whether treating acute exacerbations of bronchiectasis with oral antibiotics is effective at resolving the exacerbation more quickly than not treating with antibiotics. The results of this study will impact on national and international guidelines and substantially advance knowledge on exacerbations of childhood bronchiectasis.
Trial website
Trial related presentations / publications
A. B. Chang, K. Grimwood, A. Wilson, P. P. van Asperen, K. A. O'Grady, C. F Robertson, T. P. Sloots, P. J. Torzillo, E. J. Bailey, G. B. McCallum, I. B. Masters, C. A. Byrnes, M. D. Chatfield, H. Buntain, I. M. Mackay, and P. S. Morris. Randomised placebo-controlled trial on antibiotics for bronchiectasis exacerbations in children: rationale and protocol. Trials 13:156, 2012.
Public notes

Principal investigator
Name 33540 0
Prof Anne Chang
Address 33540 0
Menzies School of Health Research Rockland's Road, Tiwi, Darwin, NT 0810, Australia and
Lady Cilento Children's Hospital, South Brisbane, Qld 4101
Country 33540 0
Phone 33540 0
Fax 33540 0
Email 33540 0
Contact person for public queries
Name 16787 0
Prof Professor Anne Chang
Address 16787 0
Children's Health Services (Lady CIlento Children's Hospital), Stanley Street, South Brisbane, QLD 4101
Country 16787 0
Phone 16787 0
Fax 16787 0
Email 16787 0
Contact person for scientific queries
Name 7715 0
Prof Professor Anne Chang
Address 7715 0
Dept of Respiratory Medicine
Children's Health Services (Lady CIlento Children's Hospital), Stanley Street, South Brisbane, QLD 4101
Country 7715 0
Phone 7715 0
Fax 7715 0
Email 7715 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary