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ISRCTN
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ISRCTN79548440
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ClinicalTrials.gov identifier
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Public title
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The PAAD Study: Probiotics for Antibiotic Associated Diarrhoea (including Clostridium difficile) in care homes: Providing incidence data on antibiotic associated diarrhoea in care homes and evaluating care homes as a setting to conduct complex studies / drug trials
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Scientific title
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The PAAD Study: Probiotics for Antibiotic Associated Diarrhoea (including Clostridium difficile) in care homes: establishing the platform
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Acronym
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PAAD Study
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Serial number at source
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HTA 08/13/24; SPON844-10
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Study hypothesis
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PAAD is a two Stage Study:
Stage 1:
There is currently a lack of evidence regarding
1. the frequency of antibiotic prescribing and type of antibiotic prescribed in care homes and,
2. how often diarrhoea occurs associated with taking antibiotics (antibiotic associated diarrhoea (AAD), and its severity.
Therefore this study aims to provide data on the incidence of AAD including C.difficile associated diarrhoea in care homes and if there is an issue confirm the estimated sample size for a Randomised Controlled Trial (RCT) in Stage 2.
Stage 2 is a randomised controlled trial to assess whether AAD is prevented or ameliorated in care home service users receiving antibiotics by the administration of a probiotic along side the antibiotic.
The information supplied here, is for Stage 1 only.
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Lay summary
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Ethics approval
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Approval pending from the South East Wales Ethics Committee Panel B (ref: 10/WSE02/47)
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Study design
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12 month observational cohort study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Antibiotic Associated Diarrhoea in the elderly, living in care homes
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Participants - inclusion criteria
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1. Service users who are/have been admitted to the care home for >24 hours
2. Planned admission to care home of one month or more (excludes short term respite care)
3. Written informed consent/assent provided
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/10/2010
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Anticipated end date
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31/10/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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270
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Interventions
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Nine care homes in South Wales and the care home service users (residents) will be recruited for Stage 1. The main part of Stage 1 is a 12 month prospective observational study that aims to collect data (e.g. amount and type of antibiotics prescribed episodes of Antibiotic Associated Diarrhoea (AAD) and Clostridium difficile-associated diarrhoea (CDAD) and outcome, in a purposive sample of care homes. Additionally, there will be 3 sub-studies within Stage 1.
1. Main Observational Study
Data regarding symptoms, indication for prescribing, type of antibiotic, dose, route of administration and duration of antibiotic will be collected each time a participating service user is prescribed antibiotics by their GP. Should a service user who is prescribed antibiotics develop diarrhoea, either during, or within, eight weeks of stopping the antibiotic(s), a stool sample will be collected and sent to the Public Health Wales Central Microbiology Laboratory for standard microbiological stool analysis including C. difficile analysis. A stool chart will be completed for the duration of antibiotic treatment and for an additional eight weeks after the antibiotic course is completed.
2. Sub-Studies
2.1. Sub Study 1: C. difficile Prevalence
A baseline stool sample will be collected from care home service users to assess C. difficile prevalence in the Care Homes. Data about previous antibiotic use by the service user, for a 3 month period before entry to this sub-study will also be collected.
2.2. Sub Study 2: Probiotic acceptability and feasibility
This sub-study will:
2.2.1. Explore and test the acceptability, procedure and method of delivering a probiotic in conjunction with antibiotics prescribed in the course of routine care in a small number of consenting care home residents in three care homes (up to 9 in total). This is to establish the procedures and prove that a probiotic can be given to this population as part of a research study according to a protocol.
2.2.2. This sub-study will also develop and pilot a training package for care home staff in implementing the possible Randomised Controlled Trial in Stage 2.
2.3. Sub Study 3: Qualitative Study
2.3.1. Qualitative interviews will be conducted with service home users capable of consent
2.3.2. Focus groups will be conducted with family members and care home staff discussing issues around consent and assent in care home residents
2.3.3. Additional interviews with GPs regarding these issues will also be conducted.
The focus groups and interviews will also take into account issues from sub study 2 (above).
In summary, Stage 1 will identify the scale of the AAD problem in care homes, provide reliable incidence data and confirm the basis of our sample size calculation for the randomised controlled trial (RCT) in Stage 2. Stage 1 will also allow us to pilot the trial procedures and materials required for a RCT in Stage 2. If Stage 1 indicates that AAD is a rare, unimportant problem, then, based on explicit stopping rules, we will not progress to Stage 2.
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Primary outcome measure(s)
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1.Main Observational Study
1.1. To conduct prospective systematic ascertainment of the incidence of AAD in care homes
1.2. To allow an appraisal of the estimated sample size for a Randomised Controlled Trial (RCT) in Stage 2
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Secondary outcome measure(s)
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1. Main observational study
1.1. To conduct prospective systematic ascertainment of antibiotic use in care homes
1.2. To estimate the risk of AAD overall and from particular antibiotics in care home settings
1.3. To identify barriers and implementation issues in conducting a trial of AAD prevention/amelioration in a care home setting
2. Sub-studies
2.1. Sub Study 1. Prevalence:
1.1.1 To determine the prevalence of asymptomatic C. difficile carriage in service users within selected care homes.
2.2 Sub Study 2. Probiotic Feasibility and Acceptability:
2.2.1. To test the acceptability and feasibility of administering probiotic in a small number of service users
2.2.2. To pilot and develop trial procedures including modelling consent procedures
2.2.3. To develop a training package for nursing home personnel to implement the trial
2.3. Sub Study 3. Qualitative:
2.3.1. To explore the ethical and practical issues of consent and assent, particularly the topic of advanced consent, for elderly residents who may/may not have capacity to consent
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Christopher
Butler
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Address
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Professor of Primary Care Medicine
Head of Department of Primary Care and Public Health
Cardiff University
Clinical Epidemiology Interdisciplinary Research Group
School of Medicine
3rd Floor, Neuadd Meirionnydd
Heath Park
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City/town
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Cardiff
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Zip/Postcode
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CF14 4XN
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Country
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United Kingdom
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Sponsor
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Cardiff University (UK)
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Address
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30-36 Newport Road
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City/town
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Cardiff
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Zip/Postcode
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CF24 0DE
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Country
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United Kingdom
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Date applied
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06/07/2010
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Last edited
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06/07/2010
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Date ISRCTN assigned
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06/07/2010
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