|
ISRCTN
|
ISRCTN37118456
|
|
ClinicalTrials.gov identifier
|
|
|
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
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
KCH-STR-INF v1.2
|
|
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.
Please note that the anticipated start date of this trial has been updated on 29/04/2008. The previous anticipated start dates was 01/04/2008.
|
|
Ethics approval
|
Ethics approval received from the Wandsworth Research Ethics Committee, South London REC Office (1) on the 26th of February 2008 (ref: REC Ref No: 08/H0803/1).
|
|
Study design
|
The study is designed as a pragmatic cluster randomised controlled trial with blinded follow-up.
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Stroke/acute care/complications
|
|
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
|
|
Anticipated start date
|
01/07/2008
|
|
Anticipated end date
|
31/03/2010
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
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)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Lalit
Kalra
|
|
Address
|
Department of Medicine
King's College London School of Medicine
Bessemer Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE5 9PJ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7346 3487
|
|
Fax
|
+44 (0)20 7346 3195
|
|
Email
|
lalit.kalra@kcl.ac.uk
|
|
Sponsor
|
King's College Hospital NHS Foundation Trust (UK)
|
|
Address
|
Denmark Hill
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE5 9RS
|
|
Country
|
United Kingdom
|
|
Email
|
annie.atherton@kch.nhs.uk
|
|
Sponsor website:
|
http://www.kch.nhs.uk/research
|
|
Date applied
|
25/07/2007
|
|
Last edited
|
12/11/2008
|
|
Date ISRCTN assigned
|
05/09/2007
|
