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 Research0 个研究点目标入组 94 人开始时间: 2021年11月1日最近更新: 2024年9月2日

适应症

试验速览

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•1. Children and young people who are aged between 0.5-3 years (inclusive) at randomisation
•2. Written informed consent from legal guardian
•3. Diagnosed with non-progressive neurological impairment (includes stable neuromuscular abnormalities), AND
•4. 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'.

•1. 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)
•2. 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.
•3. 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
•4. Use of macrolide antibiotics within 90 days prior to eligibility
•5. Known significant hepatic disease (hepatic impairment per Child-Pugh classification C)
•6. Treatment with ergot derivatives (dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine)
•7. Recruited to another investigation medical product (IMP) trial and continuing to administer the IMP.

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