Clinical Question

Is oral antibiotic therapy noninferior to intravenous antibiotic therapy for the treatment of bone or joint infection?

Bottom Line

Oral antibiotic therapy was noninferior to intravenous antibiotic therapy for the initial 6 weeks of treatment for bone and joint infection when assessed for treatment failure at 1 year.

Major Points

Guidelines

As a result of this trial, a standard care practice which favored intravenous antibiotics for bone and joint infections may be re-evaluated, although patient and pathogen-specific factors must be taken into account for therapy decisions.

Design

- Multicenter, open-label, parallel-group, randomized, controlled noninferiority trial
- N=1,054 participants
- 6 weeks initial treatment period followed by a 1-year assessment for treatment failure
- Intravenous antibiotics (n=527) vs. oral antibiotics (n=527)
- Enrollment: June 2010 - October 2015

Population

- Participants: Adults being treated for bone or joint infection
- Inclusion criteria: Age over 18 years, with bone or joint infection, and consent provided
- Exclusion criteria: Infection not managed by surgical intervention within 7 days after the start of antibiotic therapy
- Baseline characteristics: Well-matched for age, gender, infection type, and other variables

Interventions

- Intravenous group: Intravenous antibiotics for the first 6 weeks
- Oral group: Oral antibiotics for the first 6 weeks
- Follow-on oral antibiotics were permitted post-6-weeks in both groups

Outcomes

- Primary Outcome: Definitive treatment failure within 1 year after randomization
- Secondary Outcomes: Early discontinuation of treatment, catheter complications, serious adverse events, the length of hospital stay, adherence to treatment, and patient-reported outcome measures

Criticisms

- The trial was open-label and not blinded
- Selection of appropriate oral agents relied on specialist oversight, which may not be consistently applied across different healthcare settings
- Study duration was only 1 year, thus later treatment failures beyond this period may not have been captured

Funding

- National Institute for Health Research
- NIHR Imperial College Biomedical Research Centre
- NIHR Oxford Biomedical Research Centre

Further Reading

- NEJM article link: [Link to article]