Edinburgh Clinical Trials

SBIVA

Seven versus Fourteen Days Antibiotics for Patients with Bronchiectasis Requiring Intravenous Antibiotics

Bronchiectasis affects around 300,000 people in the UK, according to British Lung Foundation research. Hospital admissions due to bronchiectasis cost the NHS around £40 M per year. International guidelines recommend that patients receive intravenous antibiotics for 14 days if they are particularly unwell, have an infection with resistant organisms, or if oral antibiotics are ineffective. The duration is based on expert advice, but there have not been any randomised placebo controlled trials telling us what length of course is best. The dilemma being that treating for too long may keep people in hospital too long or increase their risk of antibiotic side effects, whereas treating for too short a period may increase the risk of an infection soon after completion of antibiotic therapy.

We have shown both patients and clinicians would enter a trial of shorter courses of intravenous antibiotic treatment in a study in Edinburgh of 90 patients. We found patients receiving 7 days of intravenous antibiotics took longer to next flare up compared to those getting current recommendations of 14 days. This challenges the current thinking that “more is better”.  A multi-centre trial is now needed to confirm this and change the national and international guidelines 14 day treatment recommendation. This study could add to the goal of reducing inappropriate antibiotic use and reduce the chance of developing antibiotic resistance.

We will select 400 patients with bronchiectasis throughout the UK who need intravenous antibiotics. Half, at random, will receive 7 days of intravenous antibiotics and the other half will receive 14 days of intravenous antibiotics. Both groups will get standard care in addition.

The primary outcome is the duration of time elapsed between starting intravenous antibiotics until needing another course of antibiotics for a protocol defined exacerbation of bronchiectasis (up to 1 year post randomisation). We are using the internationally agreed definition of a bronchiectasis exacerbation.

Our grant proposal has been reviewed by an expert patient panel who agreed this is an important study and that any treatment prolonging the time to next needing an antibiotic is welcome. They agreed the need for a multi-centre study, advised against bringing participants into hospital for the next flare-up after the intravenous antibiotic course, and agreed that an unblinded study was better value for money in view of the costs required to blind the study. The expert patient panel helped write the lay summary. The Asthma UK- British Lung Foundation alliance will provide strategic oversight of PPI work.

We’ll present our findings at local, national, and international meetings. This study will help the NHS provide optimal care, and the findings will be of interest internationally and so we will publish the results in a high impact factor peer reviewed journal. The Asthma UK- British Lung Foundation alliance have also agreed to help disseminate the results to the public.

SBIVA

Chief Investigator: Professor Adam Hill

Number and location of participating sites (by region/ country): UK (Scotland, England, Wales and Northern Ireland) 20 sites

EudraCT number: N/A

ISRCTN number: In set up

 

Funder: Health Technology Assessment (HTA) - NIHR

 

Start and End date

Of grant award: 01 February 2023 - 31 January 2027

Of recruitment: February 2024 - August 2025

Current Status: Awaiting approval

Trial Website: N/A

Email: SBIVA.Trial@ed.ac.uk

 

UK GDPR Privacy Statement:   Information included in Participant Information Leaflet

 

Sponsor: Accord, https://www.accord.scot/

 

Chief Investigator:

Professor Adam Hill, 102 West Port, Edinburgh, Midlothian, EH3 9DN adam.hill@nhs.scot

 

Trial Manager:

Dr Jennifer Waddell, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX SBIVA.Trial@ed.ac.uk

 

Research Nurse:

Sam Donaldson, Royal Infirmary of Edinburgh, Room F2341, Near Ward 104, Edinburgh, EH16 4SA sam.donaldson@nhslothian.scot.nhs.uk

 

ECTU involvement: Trial Management, Statistics, Health Economics, Database and randomisation service