- To provide more evidence as to whether antibiotics are necessary for all exacerbations (worsening of symptoms) caused by non-cystic fibrosis (CF) bronchiectasis.
- To run a large national, multi-centre, double blind, 2 part, randomised controlled trial for children with non-cystic fibrosis bronchiectasis to determine:
- If Azithromycin or Amoxycillin-Clavulanic Acid compared to placebo, improve the resolution of respiratory exacerbations on day 14.
- If daily Azithromycin is non-inferior to Amoxycillin-Clavulanic in achieving resolution of respiratory exacerbations on day 21.
- To determine the role of viruses and other respiratory pathogens in children with non-CF bronchiectasis in relation to exacerbations.
Once thought rare, bronchiectasis is now recognised as a significant disorder. It affects one in 68 Indigenous Australians, as well as non-Indigenous children and adults living in urban and remote Australia. It is increasingly diagnosed in children and adults with ‘difficult asthma’ and chronic cough. Effective management of bronchiectasis, particularly prevention of severe exacerbations, is associated with improved long term lung function.
Evidence from well conducted intervention studies is scarce. There are no trials for the treatment of exacerbations in children with non-cystic fibrosis (CF) bronchiectasis. While some clinicians assume that antibiotics are necessary for all exacerbations, others do not. More evidence is needed to resolve the controversy, highlighting the importance of the Bronchiectasis Exacerbation Study Trial (BEST).
The trial is being conducted in five sites around Australia:
- The Queensland Children’s Respiratory Centre (Brisbane)
- Menzies School of Health Research (Darwin)
- The Royal Children’s Hospital (Melbourne)
- The Princess Margaret Hospital for Children (Perth)
- The Children Hospital at Westmead (Sydney).
Implications for policy and practice:
This study will add to the body of evidence regarding the use of antibiotics to prevent exacerbations caused by non-CF bronchiectasis.
Our research has found:
The trial is ongoing.
The study commenced in 2012 and is scheduled for completion in 2014.
- National Health and Medical Research Council (NHMRC).
- Anne Chang, Menzies School of Health Research
- Peter Morris, Menzies School of Health Research
- Colin Robertson , Royal Children’s Hospital, Melbourne
- Keith Grimwood, Queensland Children’s Medical Research Institute
- Peter Van Asperen, The Children’s Hospital at Westmead
- Andrew Wilson, Princess Margaret Hospital, Perth
- Kerry‐Ann O’Grady, Queensland Children’s Medical Research Institute
- Theo Sloots, Queensland Paediatric Infectious Disease Lab
Paul Torzillo, University of Sydney.
- Chang, A.B., Grimwood, K., Wilson, A.C., van Asperen, P.P., Byrnes C.A., O’Grady, K.A., et al (2013). Bronchiectasis exacerbation study on azithromycin and amoxicillin-clavulanate for respiratory exacerbations in children (BEST-2: study protocol for a randomised controlled trial. Trials, 14, 53.
- Chang, A.B., Grimwood, K., Robertson, C.F., Wilson, A.C., van Asperen, P.P., O’Grady, K.A., et al (2012). Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial. Trials, 13, 156.