A national feasibility study for children’'s bone and joint infections

Update Il y a 5 ans
Reference: ISRCTN65108429

Woman and Man

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Extract

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 [email protected]


Inclusion criteria

  • Paediatric bone or joint infection

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