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
Menzies School of Health Research
94 participants
Dec 15, 2021
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
Inclusion Criteria7
- Children and young people who are aged between 0.5-3 years (inclusive) at randomisation
- Written informed consent from legal guardian
- Diagnosed with non-progressive neurological impairment (includes stable neuromuscular abnormalities), AND
- One or more of the following:
- a) Received at least 2 courses of oral antibiotics for LRTI in 26 weeks prior to eligibility
- b) Have been hospitalised with a LRTI within 52 weeks prior to eligibility and completed
- c) Prescribed prophylactic antibiotics for LRTIs and undergone a 4 week ‘washout’ period'.
Exclusion Criteria8
- Progressive neuromuscular disorders such as Duchenne muscular dystrophy etc., or neurological disorders in which progressive deterioration in neurological condition are known to occur (e.g. Rett syndrome, some neurometabolic syndromes)
- Pre-existing non-neurological conditions that impact on respiratory function such as cystic fibrosis (CF), immunodeficiency etc. Children with neurological impairment known to have bronchiectasis will not be excluded.
- Known contra-indication to using (e.g. prolonged QT syndrome) or hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic or to any of the excipients contained in the study drug
- Use of macrolide antibiotics within 90 days prior to eligibility
- Known significant hepatic disease (hepatic impairment per Child-Pugh classification C)
- Treatment with ergot derivatives (dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine)
- OR
- Recruited to another investigation medical product (IMP) trial and continuing to administer the IMP.
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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 medications will be monitored using a treatment diary and withdrawals from study treatment will also be monitored.
Locations(2)
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ACTRN12621001486819