Antibiotics for Exacerbations of Non Cystic Fibrosis Bronchiectasis
Research type
Research Study
Full title
A randomised double-blind trial of 7 versus 14 days of antibiotics for exacerbations of non cystic fibrosis bronchiectasis
IRAS ID
4076
Contact name
Adam Hill
Contact email
Sponsor organisation
NHS Lothian R&D department
Eudract number
2008-005404-12
Research summary
Bronchiectasis is a debilitating long-term lung disease. Patients suffer daily cough with sputum and frequent chest infections due to swollen and permanently damaged airways. In Scotland the disease is common and over 400 patients in Edinburgh are monitored in hospital outpatient clinics. When patients develop infections or 'exacerbations' they become more unwell and need antibiotics, sometimes in hospital.
We still do not know exactly who to treat during these infections, what antibiotics to use and how long to treat for. Patients are being managed differently both in the community and in hospital. In this study we ask: 'What length of antibiotic treatment is required for exacerbations?'We will study 100 patients with exacerbations of their bronchiectasis. 50 patients will be given seven days and 50 patients will be given fourteen days of appropriate antibiotics in tablet form. The patients will be studied on four occasions over six weeks. We will take basic blood tests, test sputum samples for the number of bacteria present and for chemical markers released by swollen and irritated airways. Patients will be asked to do some basic breathing tests and a simple walking exercise test. Side effects will be recorded and a health-related quality of life questionnaire completed. Patients who are not getting better will receive an additional two weeks of antibiotics based on their sputum results.
The study will tell us whether 14 days of antibiotics is better than 7 days in prolonging the time to the next exacerbation. It will also tell us whether 14 days is more likely to make patients feel better, clear the sputum of more bacteria and increase their lung capacity. Equally we will find out whether taking antibiotics for longer causes more side effects.
The results of the study will provide valuable information for national guidelines on optimum treatment.
REC name
Scotland A REC
REC reference
08/MRE00/102
Date of REC Opinion
2 Dec 2008
REC opinion
Favourable Opinion