RecruitingPhase 3ACTRN12619001597189

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.


Sponsor

University of Liverpool

Enrollment

500 participants

Start Date

Jul 28, 2020

Study Type

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

Sex: Both males and femalesMin Age: 3 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

Children with neurological conditions such as cerebral palsy often have difficulty clearing mucus from their lungs due to muscle weakness and swallowing problems. This makes them much more prone to chest infections (lower respiratory tract infections), which can be serious — sometimes leading to hospitalisation, worsening of their condition, or even death. Despite this being a major health problem, there is very little evidence about the best way to prevent these recurring infections. The PARROT trial is a large international study (running in both Australia and the UK) testing whether a long-term course of the antibiotic azithromycin, taken once a week for 12 months, can reduce the number of chest infections and hospital admissions in children with neurological impairment. Half of the children will receive azithromycin and half will receive a placebo (an identical-tasting liquid with no active ingredient). Children and their families will be followed for up to 18 months. Your child may be eligible if they are aged 3–17 years, have a non-progressive neurological condition (such as cerebral palsy), have ongoing respiratory symptoms, and have been admitted to hospital with a chest infection or had at least two courses of antibiotics for chest infections in the past year. Children with progressive neurological conditions, cystic fibrosis, known allergy to macrolide antibiotics, or significant liver disease would not be eligible.

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.

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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 moni

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)

Queensland Children's Hospital - South Brisbane

NT,QLD,VIC, Australia

The Royal Childrens Hospital - Parkville

NT,QLD,VIC, Australia

Royal Darwin Hospital - Tiwi

NT,QLD,VIC, Australia

United Kingdom

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ACTRN12619001597189


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