Joint UK and Australia multicentre, randomised, double blind, placebo controlled pragmatic trial comparing 52 weeks of azithromycin to placebo in children with neurological impairment at risk of lower respiratory tract infection (the PARROT trial).
The effect of prophylactic antibiotics on chest infections in children with neurological impairment (Parrot) trial.
University of Liverpool
500 participants
Jul 28, 2020
Interventional
Conditions
Summary
Neurological Impairment (NI) in children is often caused by conditions such as cerebral palsy. Many children with NI are prone to chest infections which can lead to long stays in hospital, additional impairment and even premature death. Despite the suffering caused to children and their families by these infections and the high cost to health services, there is very little information on how best to prevent them. Some doctors prescribe long-term antibiotics but we don't really know whether this treatment makes any difference to the numbers of chest infections children suffer from, or whether these antibiotics can cause long term harm. The trial is looking to recruit for 500 children and young people aged 3-17 years, with NI who are at risk of chest infections, along with their parents / primary care giver to take part. Children included in the trial will be given either azithromycin or a placebo for 12 months to compare the difference. The trial is taking place in the UK and Australia and each participant will be involved for a maximum of 18 months. The aim of the trial is to find out whether 12-month's treatment with the antibiotic azithromycin reduces how often children with NI have to stay in hospital with chest infections.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Arm 1: Azithromycin The dosing regimen is based on body weight (10mg/kg rounded) and will be administered as an oral suspension 3 times weekly (Mon/Wed/Fri) for 52 weeks. Adherence will be monitored at 13, 26, 39 and 52 weeks using an IMP treatment diary and withdrawals from study treatment will also be monitored.
Locations(4)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619001597189