Joint Infection Clinical Trial
Official title:
Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study
The study will compare the outcomes of treating bone and joint infections with 6 weeks of intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic "strategy" rather than of individual antibiotics. The study will be open label, but the primary outcome will be proven failure of infection treatment, determined by pre-established objective criteria for treatment failure. The null hypothesis tested is that there will be no difference in treatment failure rates.
A long course of antibiotic therapy given by a "drip" (i.e. intravenous) is recommended
treatment for many serious bacterial infections. It is costly and inconvenient for the
patient to remain hospitalised for therapy, so outpatient antibiotic therapy (OPAT)
programmes have been established in many countries to deliver intravenous antibiotics safely
and conveniently. The majority of patients referred to OPAT programmes have bone and joint
infections. However, there is no clear evidence that bone and joint infection really require
long courses of intravenous antibiotics rather than oral antibiotics.
We will compare the outcome of treatment with intravenous versus oral antibiotic therapy for
patients with bone and joint infection. The choice of antibiotic is complex, and antibiotics
that are suitable oral choices are often not suitable intravenous choices and vice versa.
Subjects will therefore be randomized to an oral or intravenous "strategy," rather than to
individual antibiotics. Outcomes will be determined by pre-established objective criteria for
treatment failure.
We have conducted a pilot study in one centre (Oxford), recruiting approximately 200
patients, and are now expanding to include multi-centre recruitment in the UK, aiming to
recruit 1050 patients.
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