Takeaway
- Oral antibiotic therapy is non-inferior to intravenous (IV) therapy for the treatment of bone and joint infection when used during the first 6 weeks.
Why this matters
- Currently, prolonged course (4-6 weeks) of IV antibiotics is considered to be the ‘gold standard’ during the early phase of bone and joint infection treatment.
- The inclusion of oral antibiotics therapy into routine clinical practice is likely to benefit patients and provide an opportunity for substantial cost savings to the NHS.
Study design
- In the intention-to-treat (IIT) analysis, 1054 patients were randomly assigned (1:1) to receive oral (n=527) and IV (n=527) antibiotics.
- In the modified IIT (MIIT) analysis, 1015 patients were randomly assigned to receive oral (n=506) and IV (n=509) antibiotics.
- Primary outcome: proportion of participants experiencing treatment failure within 1 year.
- Funding: Health Technology Assessment programme of the National Institute for Health Research.
Key results
- In the IIT analysis, definitive treatment failures were observed in 14.04% and 12.71% patients in the IV and oral groups, respectively (risk difference, −1.38%; 90% CI, −4.94% to 2.19%).
- In the MIIT analysis, 14.62% and 13.16% of patients in the IV and oral groups, respectively, showed definitive treatment failure (risk difference, −1.46%; 90% CI, −5.03% to 2.11%).
- In a per-protocol analysis, 15.58% of patients in the IV group and 13.09% of patients in the oral group experienced definitive treatment failure (risk difference, −2.49%; 90% CI −6.31% to 1.34%).
- Except for IV catheter complications (9.37% in the IV group vs 0.96% in the oral group), no significant difference was observed in the incidence of serious adverse events and death between the 2 groups.
Limitations
- Open-label trial.
- Participants only followed up for 1 year so differences in late recurrence cannot be excluded.
References
References