Antibiotic prophylaxis for clean intermittent catheterisation v1.0
Research type
Research Study
Full title
Antibiotic treatment for intermittent bladder catheterisation: A randomised controlled trial of once daily prophylaxis (The AnTIC study)
IRAS ID
125526
Contact name
Robert Pickard
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2013-002556-32
ISRCTN Number
N/A
Research summary
The AnTIC trial is about finding out whether taking a once daily dose of antibiotic (prophylaxis) over 12 months is worthwhile to prevent repeated urinary infection in people who use intermittent catheterisation to empty their bladder, compared to the more usual approach of taking a full dose of antibiotics for a few days only when there is an active infection.
Intermittent catheterisation is commonly used by people who have difficulty emptying their bladder because of bladder muscle weakness or nerve diseases. Intermittent catheterisation is generally a very useful way to empty the bladder as it avoids having to have a catheter in all the time and protects the bladder and kidneys from further damage. However, about a third of the people who use it suffer repeated urinary infections requiring treatment with antibiotics. Repeated courses of antibiotics to treat these infections can be harmful. One option to reduce infection is to take a single daily dose of antibiotic for a prolonged period to suppress the tendency for bugs to invade the bladder (this is called ‘prophylaxis’).
We hope to recruit at least 380 people who are carrying out intermittent bladder catheterisation and who suffer from repeated urinary infections. Half will be randomised to daily antibiotic prophylaxis for a year and the other half to take a separate course of antibiotics only when an active infection occurs. Everybody who agrees to take part in the study will be asked to fill out a series of questionnaires about the infections they experience and their general health over a year and to provide regular urine specimens to see whether it is better or not to take antibiotic prophylaxis.
The study has been funded by the NIHR Health Technology Assessment programme and participants will be recruited from up to 40 NHS sites in the UK.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0196
Date of REC Opinion
1 Aug 2013
REC opinion
Favourable Opinion