RecruitingPhase 3Phase 4ACTRN12621001486819

Effect of prophylactic azithromycin on chest infections in children with neurological and neuromuscular impairment

Randomised, triple blinded, placebo trial comparing 26 weeks of azithromycin to placebo in children with neurological/neuromuscular impairment to reduce the the risk of lower respiratory tract infection


Sponsor

Menzies School of Health Research

Enrollment

94 participants

Start Date

Dec 15, 2021

Study Type

Interventional

Conditions

Summary

Neurological Impairment (NI) in children is often caused by conditions such as cerebral palsy and other neuromuscular conditions. 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 (PARROT-Junior) is a sub-study of a parent study (PARROT). In PARROT-Junior, we will recruit children aged 0.3-3 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 6 months to evaluate whether regular azithromycin reduces the frequency of chest infections. For the analysis, results from PARROT-Junior will be combined with data from the children recruited from Brisbane/Darwin in the parent study (PARROT). Our target sample size thus includes the subset of Brisbane/Darwin-enrolled children from PARROT.


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 3 Yearss

Plain Language Summary

Simplified for easier understanding

Children with neurological conditions such as cerebral palsy often experience recurrent chest infections that can lead to hospitalisation, worsening health, and even premature death. Some doctors prescribe long-term low-dose antibiotics to prevent these infections, but solid evidence about whether this is beneficial or risky is lacking. The PARROT-Junior trial is testing whether regular azithromycin — a commonly used antibiotic — reduces the frequency of chest infections in young children with neurological impairment. Children aged 6 months to 3 years are randomly assigned to receive either azithromycin or a placebo for 6 months. Their rates of chest infections, antibiotic use, hospitalisations, and any side effects are carefully tracked. Results from this trial will be combined with data from a related larger study to build a comprehensive picture of whether this preventive antibiotic approach is both safe and effective in this vulnerable group. This trial is open to infants and young children aged 6 months to 3 years who have been diagnosed with a stable, non-progressive neurological condition and have had at least two recent courses of antibiotics for a lower respiratory tract infection, or have been hospitalised with such an infection in the past year. Children with progressive neuromuscular diseases, cystic fibrosis, or known allergy to azithromycin are not 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

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 26 weeks. Adherence to the trial medicat

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 26 weeks. Adherence to the trial medications will be monitored using a treatment diary and withdrawals from study treatment will also be monitored.


Locations(2)

Queensland Children's Hospital - South Brisbane

NT,QLD, Australia

Royal Darwin Hospital - Tiwi

NT,QLD, Australia

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ACTRN12621001486819


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