The BEST Trial is a research project to see whether children with bone and joint infections can be treated with antibiotics given only by mouth, instead of initially through their vein (which is called ‘intravenously’) and then by mouth. This would mean that they can receive their care at home and would spend less time in hospital.

This is a new project and will involve approximately 214 children at 8 children’s hospitals around Australia and New Zealand. This research has been initiated by the study doctor, A/Prof Amanda Gwee and Dr Alison Boast from The Royal Children’s Hospital Melbourne.  It is sponsored by Murdoch Children’s Research Institute and has been funded by the National Health and Medical Research Council (NHMRC), HCF Research Foundation and Avant Foundation.

From the start of your hospital admission, you will receive antibiotics, either intravenously (given through your vein) or orally (taken only by mouth) to treat the bone and joint infections. You will be assigned to either the  ‘standard treatment’ group or the  ‘entirely oral antibiotic course’ group.

• ‘Standard Treatment’ group participants will receive IV antibiotics for the first 1 to 7 days and followed by oral antibiotics.
• ‘Entirely oral antibiotics’ group participants will receive the whole antibiotic treatment orally.

Your child will have appointments with the treating team at 3 weeks, 6 weeks and 12 months. The research team will also phone you after you are discharged from hospital (day 8 to 14), at 3 months and 6 months.

You can stop taking part in the project at any time. You just need to tell us so. You do not need to tell us the reason why. If you leave the project we will use any information already collected unless you tell us not to.

We are unable to say if there will be any direct benefit to you. We expect the main benefits of this study to be for others in the future. We hope that children with bone and joint infections can be treated with oral antibiotics in the future so that they can receive their care at home.

Medical treatments often have side effects. Your child may have none, some or all of the side effects listed below, and they may be mild, moderate or severe. If your child has any of these side effects or you are worried about them, please talk to us. We will also be looking out for side effects. Please tell us immediately if your child experiences any new or unusual symptoms.

Side effects of antibiotics (Cefazolin and Cefalexin) may include:

• diarrhoea,
• abdominal pain,
• nausea,
• vomiting
• thrombocytopenia, which means a low blood platelet count. This is a rare side effect.

Having a blood sample can cause some discomfort or bruising. Rarely, there could be a minor infection. If this happens, it can be easily treated without any long-term effects.

You will be closely monitored by attending clinic, blood tests, and phone calls. If there are any concerns about your child's recovery, this will be discussed with the treating doctor during your study visits. You can also contact the study team at any time.

As part of the study, we will collect blood samples from you to measure the amount of antibiotic in your blood. Where possible and in addition, we may conduct research testing on blood and other samples such as joint fluid which have been taken for routine care. Each sample will be labelled with a unique code, that means your name will not be shared with anyone outside the research team. After the samples have been tested, they will be destroyed.

In this study,  we will collect and use your personal and health information for research purposes. We can disclose this information only with your permission, except as required by law. Your information will be stored in secure databases or locked filing cabinets securely at the participating hospitals.

The following people may access your child’s information as part of this research project:

• The research team involved with this project
• Royal Children's Hospital Human Research Ethics Committee
• Therapeutic Goods Administration.

Your information will be only identifiable by researchers at the participating hospitals or research institutes. This means that your name and other personal details will stay on the information while it is used at the hospital. However, we will remove your name and other details that could identify you before we send it to the research team in other Australian hospitals or to the Therapeutic Goods Administration.

You have the right to access and correct the information we collect and store about you. This is in accordance with relevant Australian and/or Victorian privacy and other relevant laws. Please contact us if you would like to access this information.

We plan to publicise the findings of this research project in medical journals and at presentations such as conferences and workshops. The presentations could take place in Australia or overseas. Your information will be grouped together with the other children who are taking part in the project. We will present the findings from the project in such a way that you cannot be identified.

If you have any concerns and/or complaints about the project, the way it is being conducted or your rights as a research participant, and would like to speak to someone independent of the project, please contact:

Director, Research Ethics & Governance
The Royal Children’s Hospital
Phone: show phone number.

For any queries, please email the BEST Trial research team at  show email address