Plain English Summary
Background and study aims
Taking antibiotics kills off bacteria that cause disease. However, antibiotics also kill the bacteria that help keep the harmful bacteria in check, often causing diarrhoea. Older people, especially those who are frail and have multiple health problems, are particularly prone to getting diarrhoea after taking antibiotics, including diarrhoea caused by the bacterium Clostridium difficile. Many frail elderly people live in care homes and they are often prescribed antibiotics for conditions such as urine or chest infections. Because no one knows exactly how often and what types of antibiotics are prescribed in care homes in the UK, and how often diarrhoea occurs as a consequence and how serious it is, the aim of this study is to provide this information.
Who can participate?
Residents in nine care homes
What does the study involve?
Information is collected each time a participating resident is prescribed antibiotics by their GP. If a resident who is prescribed antibiotics develops diarrhoea either during or within 8 weeks of stopping the antibiotic(s), a stool sample is collected and sent for analysis including C. difficile analysis.
What are the possible benefits and risks of participating?
The results of this study may be useful for guiding future antibiotic treatment decisions and service planning.
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
October 2010 to October 2011
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Christopher Butler
Trial website
Contact information
Type
Scientific
Primary contact
Prof Christopher Butler
ORCID ID
Contact details
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
Cardiff
CF14 4XN
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 08/13/24; SPON844-10
Study information
Scientific title
The PAAD study: Probiotics for Antibiotic-Associated Diarrhoea (including Clostridium difficile) in care homes: establishing the platform
Acronym
PAAD
Study hypothesis
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 alongside the antibiotic.
The information supplied here is for Stage 1 only.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081324
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0011/52211/PRO-08-13-24.pdf
Ethics approval
South East Wales Ethics Committee Panel B, ref: 10/WSE02/47 – approval pending
Study design
12-month observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Antibiotic-associated diarrhoea in the elderly, living in care homes
Intervention
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 three 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 8 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 8 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 nine 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
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 probiotics 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
Overall trial start date
01/10/2010
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
270
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/10/2010
Recruitment end date
31/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiff University
Cardiff
CF14 4XN
United Kingdom
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23937972
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25331573
Publication citations
-
Results
Wood F, Prout H, Bayer A, Duncan D, Nuttall J, Hood K, Butler CC, , Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales., Trials, 2013, 14, 247, doi: 10.1186/1745-6215-14-247.
-
Results
Hood K, Nuttall J, Gillespie D, Shepherd V, Wood F, Duncan D, Stanton H, Espinasse A, Wootton M, Acharjya A, Allen S, Bayer A, Carter B, Cohen D, Francis N, Howe R, Mantzourani E, Thomas-Jones E, Toghill A, Butler CC, Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes., Health Technol Assess, 2014, 18, 63, 1-84, doi: 10.3310/hta18630.