Title: A randomised controlled trial of different strategies of antibiotic use to reduce the incidence and consequences of chest infection in acute stroke patients with swallowing problems
Funder: Department of Health (England)

Abstract: Background Nearly 40% of acute stroke patients have dysphagia, of whom up to 20% will develop aspiration pneumonia. This is associated with increased probablity of death, institutionalisation, poor participation in rehabilitation, increased duration of hospitalisation and increased costs of care. Although current guidelines have recommendations on the assessment, positioning and feeding of stroke patients to prevent chest infections, there are no guidelines for antibiotic use in these patients. Only 3 trials on antibiotic prophylaxis are available and show safety but not effectiveness, possibly because they include non-dysphagic patients, use mortality rather than infections as the end point and ignore duration of hospitalisation, participation in rehabilitation and costs as important outcomes. Aims The aim of this cluster randomised trial in London and the South East is to evaluate the effectiveness and safety of prophylactic use of antibiotics (an "act first" approach) compared with monitoring for infection and treatment if necessary (a "wait and watch" approach) in reducing aspiration pneumonia and mortality whilst improving participation in rehabilitation and functional outcomes in acute stroke patients with dysphagia on clinical assessment. Whether this approach results in reduced duration of hospitalisation and costs will also be assessed. Clinical and costs indicators will be used as co-primary outcome measures will be adopted, to reflect the equal importance of clinical and economic endpoints in assessing the effectiveness of health interventions. Plan of Investigation We will study 800 stroke patients with dysphagia admitted to 20 stroke units (13 in London) . We will use cluster randomization to allocate units to either giving evidence based antibiotic treatment for aspiration pneumonia as prophylaxis or to giving antibiotic treatment only if signs of pneumonia develop. The clinical primary outcome measure is the incidence of chest infections in the first 14 days after stroke onset. The primary cost outcome is the hospital cost for the presenting stroke. We will also monitor mortality, antibiotic related side effects, participation in rehabilitation and days spent in hospital up to 3 months. Analysis will be performed masked to allocation.Data will be collected by local staff. Trial management, data collation and analysis will be done by researchers. Potential Impact Prophylactic use of antibiotics is expected to result in a 50% reduction in the rate of incident pneumonia from 16-19% to 6-8% in stroke patients with dysphagia. This is likely to be associated with a 3-5% reduction in mortality at 3 months, less morbidity and acute medical bed use, fewer days lost to rehabilitation, improved patient quality of life, shorter duration of hospital stay and better functional outcomes. It is estimated that antibiotics are used currently in as many as 60% of dysphagic patients in the first week of stroke to treat suspected infections. Prophylactic use of antibiotics may result in a modest increase of 15-20% in overall antibiotic costs, but if this practice reduces the overall length of stay by even 2 days, it will save 43,000 bed days in London every year.


Research activity codes: 3.3 NUTRITION AND CHEMOPREVENTION
Health categories: STROKE;INFECTION