Plain English Summary
Background and study aims
Bone and joint infections in children are relatively uncommon. The collective term for them is osteoarticular infections or OAI. They need to be treated promptly and effectively in order to prevent long term damage. Currently there is no national agreement amongst doctors regarding the best way to treat these infections. Usually children with bone and joint infections are treated with antibiotics given into a vein, known as intravenous or IV antibiotics, followed by oral antibiotics. What we do not know is how long it is necessary to give intravenous antibiotics before it is safe to switch to oral antibiotics. IV antibiotics also have risks, such as infection of the veins because of the lines used to give the antibiotics. These risks are reduced by shortening the duration of IV antibiotics. Oral antibiotics can be taken at home, reducing the length of hospital stay. This study aims to ascertain the spectrum and severity of bone and joint infections in children in the UK. We will also collect information on how different hospitals investigate and treat these infections both with antibiotics and with surgery where necessary. After this we aim use the information to see if it is possible to do a study looking at shorter courses of IV antibiotics for these infections, using this database as a guide.
Who can participate?
All children aged between 3 months and 16-years-old presenting to participating hospitals during a 6 month period with a diagnosis of bone or joint infection will be included in this database, unless they request that their data is not entered.
What does the study involve?
The database will be advertised using posters on wards at participating centres. Patient data will be entered via web-based forms into the database by research doctors and nurses at these centres.
At 5 specific centres additional tests will also be done and linked to the database. A test called polymerase chain reaction (PCR) looking for bacterial DNA in samples routinely taken from patients with bone and joint infection will also be tested. This test shows what bugs are causing the infection more often than techniques such as trying to grow bacteria, which is the current method. It may therefore allow treatment to be focused and rationalised and also identify bacteria that are resistant or more likely to cause complications. We will also be doing this test on a throat swab taken from children at these centres to see if they carry the bacteria causing the OAI in their throat. At the 5 centres participating in PCR patients and their parents will also be asked for consent for an additional blood sample to be taken at a time when routine bloods are being done. This sample will be used to look for particular genes involved in the immune system, and the proteins they produce in response to infection.
What are the possible benefits and risks of participating?
There will be no direct benefit to the patient of being in the study. PCR results and blood results will not be done in real time, and will therefore not be available to affect the patients treatment. There are also no risks associated with participating in this study as it is a service evaluation, and additional samples are non-invasive.
Where is the study run from?
University Hospital Southampton NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2013 to July 2013
Who is funding the study?
UK NIHR Health Technologies Assessment Programme
Who is the main contact?
Sarah Olsen
sarah.olsen@liverpool.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Saul Faust
ORCID ID
Contact details
NIHR Wellcome Trust Clinical Research Facility
University of Southampton
University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 4989
s.faust@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 10/146/01
Study information
Scientific title
Duration of intravenous antibiotic therapy for children with acute osteomyelitis or septic arthritis: a feasibility study
Acronym
Study hypothesis
Currently there is no international & little UK consensus regarding the route or duration of antibiotic treatment for acute OM/SA in children. To assess the feasibility of an RCT to determine the safety of early oral switch from IV therapy, it isessential to also gain information to determine the total length of therapy to be used in a trial. If this study determines an RCT is not feasible, this data will allow us to produce a national consensus guideline derived from the clinician survey. In stage 1, we aim to conduct a service evaluation of OM/SA in children 1 month (lower limit of clindamycin licence) to 16 years including routine micro & additional new molecular test. In stage 2 we will evaluate the feasibility of performing an RCT (as above). By assessing case spectrum & current NHS practice, we will gain consensus on the proposed trial total duration of therapy.
This study will canvas consumers & clinical stakeholders to report on:
1. Current case load, disease spectrum & clinical practice in the diagnosis & treatment of OM/SA in secondary & tertiary UK care
2. Feasibility of performing targeted molecular tests on routinely collected samples sent to a HPA Regional Lab
3. Feasibility of carrying out an RCT into antimicrobial therapy route & duration in paediatric acute OM/SA. This will be achieved by obtaining qualitative & quantitative data on:
3.1. Willingness of clinicians to randomise to proposed protocol
3.2. Willingness of patients & parents to be randomised
3.3. No of patients seen
3.4. Clinical stakeholder & consumer perception of relevant outcomes
3.5. Identification of non-inferiority margins of acceptable outcomes
3.6. Likely RCT recruitment rates
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1014601
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/81142/PRO-10-146-01.pdf
Ethics approval
Not provided at time of registration
Study design
Feasibility study with quantitative diagnostic and qualitative methods
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Paediatric bone or joint infection
Intervention
At the majority of participating centres' patient data will be entered into the database by the team looking after the patient or local research nurse. This will include patient demographics such as age, ethnicity and gender, dates of presentation to hospital, blood tests and imaging done, and treatment given. We will also collect the blood and microbiology results, reports of imaging and details of surgery.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Quantitative and qualitative data
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/02/2013
Overall trial end date
31/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All children aged 3 months to 16 years presenting to participating hospitals within a 6 month period with a diagnosis of septic arthritis and/or osteomyelitis
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
All children with condition at participating hospitals
Participant exclusion criteria
1. Infants under 3 months, and adolescents over 16 years
2. Patients who request not to be included in the database
Recruitment start date
01/02/2013
Recruitment end date
31/07/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NIHR Wellcome Trust Clinical Research Facility
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University Hospital Southampton NHS Foundation Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
heidi.nield@uhs.nhs.uk
Sponsor type
Hospital/treatment centre
Website
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
Federal/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