التفاصيل البيبلوغرافية
| العنوان: |
Oral versus intravenous antibiotic treatment for bone and joint infections (OVIVA): study protocol for a randomised controlled trial |
| المؤلفون: |
Li, Ho, Scarborough, Matthew, Zambellas, Rhea, Cooper, Cushla, Rombach, Ines, Walker, A., Lipsky, Benjamin, Briggs, Andrew, Seaton, Andrew, Atkins, Bridget, Woodhouse, Andrew, Berendt, Anthony, Byren, Ivor, Angus, Brian, Pandit, Hemant, Stubbs, David, McNally, Martin, Thwaites, Guy, Bejon, Philip |
| بيانات النشر: |
BioMed Central Ltd. |
| سنة النشر: |
2015 |
| المجموعة: |
BioMed Central |
| مصطلحات موضوعية: |
Bone and joint infection, Oral, Intravenous, Antibiotic, Non-inferiority, Treatment failure |
| الوصف: |
Background Bone and joint infection in adults arises most commonly as a complication of joint replacement surgery, fracture fixation and diabetic foot infection. The associated morbidity can be devastating to patients and costs the National Health Service an estimated £20,000 to £40,000 per patient. Current standard of care in most UK centres includes a prolonged course (4–6 weeks) of intravenous antibiotics supported, if available, by an outpatient parenteral antibiotic therapy service. Intravenous therapy carries with it substantial risks and inconvenience to patients, and the antibiotic-related costs are approximately ten times that of oral therapy. Despite this, there is no evidence to suggest that oral therapy results in inferior outcomes. We hypothesise that, by selecting oral agents with high bioavailability, good tissue penetration and activity against the known or likely pathogens, key outcomes in patients managed primarily with oral therapy are non-inferior to those in patients treated by intravenous therapy. Methods The OVIVA trial is a parallel group, randomised (1:1), un-blinded, non-inferiority trial conducted in thirty hospitals across the UK. Eligible participants are adults (>18 years) with a clinical syndrome consistent with a bone, joint or metalware-associated infection who have received ≤7 days of intravenous antibiotic therapy from the date of definitive surgery (or the start of planned curative therapy in patients treated without surgical intervention). Participants are randomised to receive either oral or intravenous antibiotics, selected by a specialist infection physician, for the first 6 weeks of therapy. The primary outcome measure is definite treatment failure within one year of randomisation, as assessed by a blinded endpoint committee, according to pre-defined microbiological, histological and clinical criteria. Enrolling 1,050 subjects will provide 90 % power to demonstrate non-inferiority, defined as less than 7.5 % absolute increase in treatment failure rate in ... |
| نوع الوثيقة: |
report |
| اللغة: |
English |
| Relation: |
http://www.trialsjournal.com/content/16/1/583 |
| الاتاحة: |
http://www.trialsjournal.com/content/16/1/583 |
| Rights: |
Copyright 2015 Li et al. |
| رقم الانضمام: |
edsbas.AC889361 |
| قاعدة البيانات: |
BASE |