| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN37118456 |
| Date ISRCTN assigned | 05/09/2007 |
| Local reference number(s) | KCH-STR-INF v1.2 |
| Public title | A cluster randomised trial of different strategies of antibiotic use to reduce the incidence and consequences of chest infection in acute stroke patients with swallowing problems |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Stroke/acute care/complications |
| Study hypothesis | The main hypothesis for the study is that prophylactic use of antibiotics (an "act first" approach) in acute stroke patients with swallowing problems on a bedside clinical assessment will be better than the current practice of monitoring for infection and treatment if necessary (a "wait and watch" approach) in reducing chest infections and their consequences in stroke patients. |
| Design/methodology | The study is designed as a pragmatic cluster randomised controlled trial with blinded follow-up. |
| Research ethics review | Ethics approval pending as of 25/07/2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | The study will be undertaken in hospital based stroke units that have a defined policy for acute stroke care and participate in the National Stroke Audit (NSA). It will include:
1. Ischaemic or haemorrhagic stroke patients within 48 hours of symptom onset
2. Unable to swallow because of impaired consciousness levels or have failed the clinical bedside swallowing assessment performed by a trained professional |
| Participants - exclusion criteria | 1. Pre-existing swallowing problems
2. Evidence of infection or pyrexia at the time of admission
3. Allergy to penicillins or macrolides
4. Antibiotic treatment within the week prior to inclusion
5. Lack of consent from the patient or next of kin |
| Patient information material |
|
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Ongoing |
| Target number of participants | 800 |
| Interventions | All patients will be managed in stroke unit settings and receive supportive care for dysphagia patients as recommended by the Royal College of Physicians Stroke Guidelines. The intervention being investigated is an "act first" strategy of prophylactic antibiotic use versus a "wait and watch" strategy of monitoring and treating only if signs of infection develop. Pathogens involved in aspiration pneumonia include gram negative bacilli (40 - 60%) and gram positive cocci (20 - 40%), with anaerobes being rare.
Treatment of aspiration pneumonia is currently empirical, and the British Thoracic Society recommends a combination of a cephalosporin with a macrolide as initial treatment. However, cephaolosporins are associated with a high incidence of C difficile infections, the reduction of which is a high priority NHS target. Many hospital guidelines prefer the use of amoxycillin as the first line antibiotic, hence we will use amoxicillin (with or without clavulanate potassium) as the antibiotic of preference.
In the "act first" group, prophylactic treatment with amoxicillin (or equivalent co-amoxyclav) and clarithromycin will be given for 7 days via a Nasogastric (NG) tube or intravenously if the patient has no NG access. Patients in the "wait and watch" group will be monitored for chest infections and empirical treatment will be commenced with antibiotics recommended as recommended by hospital infection policy or indicated by microbiological tests. |
| Primary outcome measure(s) | The clinical primary outcome measure is the incidence of chest infections in the first 14 days after stroke onset. This will be defined as a temperature greater than 37.5°C on two consecutive measurements or a single measurement of greater than 38.0°C with chest symptoms and one or more of the following:
1. White cell count greater than 11,000/mL
2. Pulmonary infiltrate on chest x-rays
3. Positive microbiology cultures
The primary cost outcome measure will be the total hospital costs (acute and rehabilitation) for the initial episode of care, calculated as a product of costs per day for type of care (standardised NHS tariff) and number of days spent in each care setting. |
| Secondary outcome measure(s) | 1. Adverse events related to antibiotic use including:
1.1. Antibiotic related side-effects
1.2. New onset of Methicillin Resistant Staphylococcus Aureus (MRSA) infection
1.3. C. difficile diarrhoea
2. Mortality, institutionalisation and measures of activity (Functional Independence Measure), participation (Rankin Scale), mood (Hospital Anxiety and Depression Scale) and quality of life (Euroqol 5D and Visual Analogue Scale [VAS]) at three months
3. Total duration of hospital stay
Secondary economic outcome measures will include Incremental Cost-Effectiveness Ratios (ICERs) and Quality-Adjusted Life-Years (QALY) gained by the intervention. |
| Sources of funding | National Institute of Health Research (UK) (ref: PB-PG-0906-11103) |
| Sponsor name | King's College Hospital NHS Foundation Trust (UK) |
| Sponsor details | Denmark Hill
London
United Kingdom
SE5 9RS |
| Sponsor email | annie.atherton@kch.nhs.uk |
| Sponsor website | http://www.kch.nhs.uk/research |
| Contact name | Prof Lalit Kalra |
| Contact details | Department of Medicine
King's College London School of Medicine
Bessemer Road
London
United Kingdom
SE5 9PJ |
| Contact telephone | +44 (0)20 7346 3487 |
| Contact fax | +44 (0)20 7346 3195 |
| Contact email | lalit.kalra@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN37118456 |
| Date last extracted from ISRCTN register | 17/04/2008 |
