Prophylactic antibiotics to prevent chest infections in children with neurological impairment

Phase 3

Completed

• Conditions: eurological impairment; Nervous System Diseases

• Registration Number: ISRCTN71955516
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-22
• Study Completion: 2023-12-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Children and young people who are aged between 3-17 years at randomisation
2. Written informed consent from participant (or appropriate person if incapacitated / minor)
3. Participant (or appropriate person if incapacitated / underage) and caregiver have a good understanding of the English language
4. Diagnosed with non-progressive, non-neuromuscular NI*
5. Persistent respiratory symptoms**
6. One or more of the following:
6.1. Received at least 2 courses of oral antibiotics for LRTI in 52 weeks prior to eligibility
6.2. Have been hospitalised with a LRTI within 52 weeks prior to eligibility and completed 13 week ‘washout’ period (where applicable)***
6.3. Prescribed prophylactic antibiotics for LRTIs and undergone a 13 week ‘washout’ period***

* Most will likely have cerebral palsy. However, some children may have no formal diagnosis to account for their symptoms.
** Persistent respiratory symptoms defined by LRSQ-Neuro score of > = 95%CI for age
*** Must have undergone a 13 week‘washout’ period where administered IV antibiotics during hospitalisation or have been previously prescribed and administered prophylactic or nebulised antibiotics

Exclusion Criteria

1. Any neuromuscular disorders including SMA, 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 respiratory functions such as CF, immunodeficiency etc. Note: Children with NI known to have bronchiectasis will not be excluded
3. Known contra-indication to using or hypersensitivity to azithromycin, erythromycin, 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. Child/young person already taking prophylactic antibiotics for non-respiratory causes (e.g. UTIs)
8. Previously randomised in PARROT
9. Recruited to another IMP trial and continuing to administer the IMP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children and young people (3-17 years) hospitalised* at their recruiting or designated centre with Lower Respiratory Tract Infection (LTRI) over the 52-week intervention period, recorded at 4, 8, 13, 17, 21, 26, 30, 34, 39, 43, 47 and 52 weeks<br><br>*Hospitalisation includes those who are admitted to hospital for only a short period with LTRI e.g. 12 hours and go home with a course of antibiotics. However, if participants are hospitalised again within 2 weeks of the initial admission, this will be classified as the same event