Condition category
Infections and Infestations
Date applied
08/11/2012
Date assigned
12/11/2012
Last edited
10/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.uhs.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/05/2016: No publications found, verifying study status with principal investigator.