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Welcome
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11 October 2008
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| [ Print-friendly version ] |
| Bone Biopsy and AntiBiotics study |
| ISRCTN | ISRCTN14961624 |
| ClinicalTrials.gov identifier | |
| Public title | Bone Biopsy and AntiBiotics study |
| Scientific title | Evaluation of the use of bone biopsy to determine antibiotic choice in the management of osteomyelitis of the foot in diabetes: BBAB study |
| Acronym | BBAB |
| Serial number at source | N/A |
| Study hypothesis |
There is no consensus on the best treatment of osteomyelitis of the foot in diabetes - which is a common and potentially disabling problem. Many centres choose antibiotics with a broad spectrum antibacterial activity, and prescribe them for many weeks or months. While this approach is successful in the majority of cases and can reduce the need for surgery, it is associated with an increased risk of side-effects (including infection with bacteria, such as Clostridium difficile) and encourages the emergence of resistant organisms, such as methicillin resistant Staphylococcus aureus [MRSA]).
Some expert bodies (including the Infectious Diseases Society of America and the International Working Group on the Diabetic Foot of the International Diabetes Federation) recommend that antibiotic choice is targeted on the basis of the results of culture of a specimen of bone obtained under local anaesthetic (bone biopsy), but this is not widely practised. Nevertheless, the use of bone biopsy in this way appeared to improve outcome in one recent study from France, even though this study was flawed by not being randomised and it is possible that other factors contributed to the differences observed. There is a clear need to establish the benefits and adverse effects of undertaking bone biopsy to guide antibiotic use and that is the purpose of this study. If the apparent benefit of bone biopsy is established, it will have an immediate impact on routine clinical care. |
| Ethics approval | Ethics approval received from the Leicestershire, Northamptonshire and Rutland REC 2 on the 11th August 2008. |
| Study design | Randomised controlled trial |
| Countries of recruitment | France, Germany, Italy, Sweden, United Kingdom |
| Disease/condition/study domain | Osteomyelitis of the foot in diabetes |
| Participants - inclusion criteria |
1. Type 1 or type 2 diabetes mellitus
2. Aged greater than or equal to 18 years, either sex 3. Previously undiagnosed infection of bone in the foot (excluding disease limited to the tibia and or fibula), which is either definite or strongly suspected on clinical grounds 4. Able and willing to give written informed consent |
| Participants - exclusion criteria |
1. Critical ischaemia: clinical or other criteria which suggest to the managing clinician that bone biopsy is relatively contraindicated
2. Frailty or disability which would mean that participation in the study might have an adverse effect on patient well being and mood 3. Pregnancy or the possibility of the occurrence of pregnancy during the study period 4. Those who are unwilling or unable to consent |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 31/08/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions | Patients will be randomised to two groups. The first will have a bone biposy, the culture of which will allow the investigators to target the antibiotics given. The second group will not be biopsied but will have broad spectrum antibiotics given. Both groups will have treatment for at least six weeks with antibiotics, but will be followed up for six months. |
| Primary outcome measure(s) | The incidence at six months of apparent arrest of bone infection without amputation, measured at six months. |
| Secondary outcome measure(s) |
1. Incidence and level of amputation (major or minor)
2. Survival: death related directly or not to infection of the foot 3. Incidence of reactivated or recurrent infection 4. Prevalence of active ulceration (persistent, reactivated or recurrent) at the end of the study 5. Days in hospital (for reasons both related or not to the infection) 6. Complications of bone biopsy 7. Adjustment of chosen antibiotic regimen 8. Duration of antibiotic treatment (intravenous and oral) 9. Infection or colonisation after the initiation of antibiotic treatment of ulcers on either foot (or other clinical infections) with MRSA and/or multiresistant organisms (MDROs): bacteria that are resistant to antibiotics which are typically used in their treatment, e.g., MRSA, vancomycin-resistant enterococci (VRE), or extended-spectrum beta lactamases (ESBL) producing gram-negative bacilli 10. Other superinfections, side-effects and adverse events (including C. difficile diarrhoea) occurring at any stage in the period of follow-up 11. Comparison of the results of baseline microbiological sampling from superficial soft tissue, deep soft tissue and bone 12. Measurement of health outcome, by results of EuroQoL instrument (EQ-5D) at 6 and 12 months after randomisation, and change from baseline Outcomes will be measured at six months. |
| Sources of funding | Moulton Charitable Foundation (UK) |
| Trial website | http://www.futu.co.uk/ |
| Publications | |
| Contact name | Prof William Jeffcoate |
| Address |
Foot Ulcer Trials Unit
David Evans Medical Research Centre Nottingham University Hospitals NHS Trust City Campus |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Tel | +44 (0)115 840 5859 |
| Fax | +44 (0)115 840 5859 |
| william.jeffcoate@futu.co.uk | |
| Sponsor | Nottingham University Hospitals NHS Trust (UK) |
| Address |
Queens Medical Centre
Derby Road |
| City/town | Nottingham |
| Zip/Postcode | NG2 2UH |
| Country | United Kingdom |
| Tel | +44 (0)115 970 9049 |
| Fax | +44 (0)115 849 3295 |
| david.hetmanski@nottingham.ac.uk | |
| Sponsor website: | http://www.qmc.nhs.uk/ |
| Date applied | 29/05/2008 |
| Last edited | 21/08/2008 |
| Date ISRCTN assigned | 09/06/2008 |
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