STATIC Study
Research type
Research Study
Full title
STudy of Antibiotic Treatment In Children with chronic cough
IRAS ID
189405
Contact name
Francis J Gilchrist
Contact email
Sponsor organisation
University Hospitals of North Midlands
Eudract number
2015-005658-36
ISRCTN Number
ISRCTN88611534
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Protracted Bacterial Bronchitis (PBB) is a type of chest infection which causes children to cough throughout the day and night, often for many months. This is upsetting for the children and their families as it disrupts sleep and affects attendance at nursery and school. Antibiotics can stop the cough but it often comes back. We do not know how long the child should receive antibiotics for, or why the cough frequently returns. This study will answer these questions. It will also find out how often the cough comes back.
As part of their normal care, children with a wet cough lasting longer than four weeks often undergo a camera test of their lungs (bronchoscopy) to find the bug causing the cough. One hundred and two children with this type of cough who attend Royal Stoke University Hospital or Birmingham Children's Hospital will take part. After the bronchsocopy, all the children will be given an antibiotic medicine by mouth but a computer will decide randomly if they receive two or six weeks treatment. Before and after treatment the parents will record how bad is their child’s cough and the child will also perform a special kind of blowing test known as lung clearance index. We can then work out if two or six weeks of antibiotics is best. The parents of the children whose cough gets better will be contacted every month for one year to ask if the cough has returned. If it does return the child
will be asked to provide a spit sample to find out if it is the same or a different bug that has caused the cough to return.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0047
Date of REC Opinion
7 Apr 2016
REC opinion
Further Information Favourable Opinion