Oral versus intravenous antibiotics for bone and joint infection

• Research type

  Research Study

• Full title

  Randomized open label study of oral versus intravenous antibiotic treatment for bone and joint infections requiring prolonged antibiotic treatment: Preliminary study in a single centre.

• IRAS ID

  31759

• Contact name

  Philip Bejon

• Sponsor organisation

  Oxford Radcliffe Hospitals NHS Trust

• Eudract number

  2009-015744-42

• ISRCTN Number

  n/a

• Research summary

  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. A trial with sufficient statistical power to change practice will need to include 950 patients. In order to determine whether such a large trial is justified, we propose beginning in one centre (Oxford) to establish the feasibility of the trial design and to obtain preliminary data that might indicate a marked disadvantage of oral antibiotics, which would preclude a larger trial.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/109

• Date of REC Opinion

  3 Dec 2009

• REC opinion

  Further Information Favourable Opinion