Prophylactic Antibiotics to Prevent Chest Infections in Children with Neurological Impairment
Aim of the study
PARROT aims to find out whether 12 months of treatment with an antibiotic called azithromycin reduces how often children and young people with neurological (NI) have to stay in hospitals with chest infections.
- Children and young people who are aged between 3-17 years (inclusive) at randomisation
- Written informed consent from the participant (or appropriate person if incapacitated/minor)
- Participant (or appropriate person if incapacitated/underage) and caregiver have a good understanding of the English language
- Diagnosed with non-progressive, non-neuromuscular NI
- Persistent respiratory symptoms
- One or more of the following:
- Received at least 2 courses of oral antibiotics for lower respiratory tract infection (LRTI) in 52 weeks prior to eligibility
- Have been hospitalised with a LRTI within 52 weeks prior to eligibility and completed 8 week ‘washout’ period (where applicable)
- Prescribed prophylactic antibiotics for LRTIs and undergone an 8 week ‘washout’ period
- Any neuromuscular disorders or neurological disorders in which progressive deterioration in neurological condition are known to occur
- Pre-existing non-neurological conditions that impact respiratory functions such as CF, immunodeficiency etc.
- Known contra-indication to using or hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotics, 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
- Treatment with ergot derivatives (dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine)
- Child/young person already taking prophylactic antibiotics for non-respiratory causes
- Previously randomised in PARROT
- Recruited to another investigational medicinal product (IMP) trial and continuing to administer the IMP
What participating in the study involves
1. You will be asked to write your name on a form
This form is to say you understand the study and what will happen. You will be given your own copy of the form to keep.
2. You will be asked to take some medicine 3 times a week for 12 months
You will receive either:
- A medicine (antibiotic) called azithromycin
- A liquid that will look and taste the same as azithromycin but will have no medicine in it (called a placebo)
You will not know what you have. Your mum, dad or the person looking after you and the doctors and nurses looking after you will not know either.
3. The research team at your hospital will contact your mum, dad or the person looking after you to check how you are:
• Monthly; by telephone or email
• Every 3 months; face-to-face follow-up where possible
You will be asked questions, including how you are, you may be weighed and you will be given more of your treatment.
4. At the start and end of the study your mum, dad or the person who looks after you will keep a diary about how well you sleep.
They may also keep a record of how well they sleep.