OVIVA

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Scarborough M, et al. "Oral versus Intravenous Antibiotics for the Treatment of Bone and Joint Infection (OVIVA): A Multicentre Randomized Controlled Trial". The Bone and Joint Journal. 2017. 99-B(SUPP 22 42):.
PubMed

Clinical Question

In adult patients with bone or joint infection requiring at least 6-weeks of antibiotic therapy without sepsis or bacteremia, is treatment with oral antibiotics non-inferior to intravenous therapy for the first 6 weeks of therapy.

Bottom Line

Major Points

Guidelines

Design

  • Multicenter, parallel group, randomized (1:1), open label, non-inferiority trial
  • N=1054
    • Intravenous Antibiotics (n=527)
    • Oral Antibiotics (n=527)
  • Setting: 26 National Health System funded hospitals in the UK
  • Enrollment:
  • Mean follow-up:
  • Analysis: Intention-to-treat; Inferiority margin of 7.5%
  • Primary Outcome: Proportion of patients with definitive treatment failure within one year of randomization

Population

Inclusion Criteria

  • ≥ 18 years old
  • Clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics
  • Received ≤ 7 days of IV therapy from the date of definitive surgery or the start of planned curative treatment in patients managed non-operatively
  • Life expectancy > 1 year

Exclusion Criteria

  • Staphylococcus aureus bacteraemia within past month or at presentation
  • Endocarditis on presentation or within past month
  • Mild osteomyelitis not requiring 6 weeks of therapy per judgement of clinician
  • Septic Shock
  • Infection where no oral option is a viable option
  • Non-bacterial infection

Baseline Characteristics

  • Demographics: Median age 60
  • Physiologic parameters:
  • Anthropomorphics: Weight
  • Labs:
  • Site of infection: lower limb (hip / knee / foot) 81%, upper limb 10%, spine 7%
  • Causative bacteria:
    • Gram Positive: Staphylococcus aureus 38%, coagulase-negative staphylococci 27%, streptococci 15%
    • Gram-negative bacteria 22%
  • Antibiotic utilized
    • IV Therapy: glycopeptides 41%, cephalosporins 33%
    • Oral Therapy:

Interventions

Outcomes

Comparisons are Intravenous vs. Oral therapy.


Primary Outcomes

Per-protocol n=1015

Clinical Treatment Failure at 1-year
14.6% vs. 13.2%

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

  • Incidence of serious adverse events was very high at 86%

Funding

NIHR Health Technology Assessment Programme (Project number 11/36/29)

Further Reading


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