Oral antibiotic therapy is noninferior to IV antibiotic therapy when used in the first 6 weeks of treatment for complex bone and joint infections, according to results from OVIVA, a randomized controlled trial.
The findings, published today in The New England Journal of Medicine, “challenge a widely accepted standard of care,” noted Ho-Kwong Li, MRCP, from the Oxford University Hospitals NHS Foundation Trust, and colleagues.
“Complex bone and joint infections are typically managed with surgery and a prolonged course of treatment with intravenous antibiotic agents,” they wrote. “The preference for intravenous antibiotics reflects a broadly held belief that parenteral therapy is inherently superior to oral therapy, a view supported by an influential 1970 article that suggested that ‘... osteomyelitis is rarely controlled without the combination of careful, complete surgical debridement and prolonged (4 to 6 weeks) parenteral antibiotic therapy ... .’ However, intravenous therapy is associated with substantial risks, inconvenience, and higher costs than oral therapy.”
In OVIVA, Li and colleagues enrolled 1,054 adults being treated for bone or joint infections at 26 health centers in the United Kingdom and randomly assigned them evenly to receive oral or IV antibiotics within 7 days after surgery — or 7 days after the start of antibiotic treatment if surgery was not needed — to complete the first 6 weeks of therapy. The primary endpoint was definitive treatment failure within 1 year, and the noninferiority margin was 7.5 percentage points.
According to the findings, treatment failure occurred in 14.6% of participants in the IV group compared with 13.2% in patients who received oral antibiotics. In an intent-to-treat analysis, the researchers reported observing a –1.4 percentage point (90% CI, –4.9 to 2.2; 95% CI, –5.6 to 2.9) difference in the risk for definitive treatment failure between the oral vs. IV groups. This indicated noninferiority, a finding supported by complete-case, per-protocol and sensitivity analyses, Li and colleagues said.
According to the study, no significant difference in the incidence of serious adverse events was observed between the groups. Some 9.3% of participants in the IV group had catheter complications compared with 1% in the oral group.
“We found that appropriately selected oral antibiotic therapy was noninferior to intravenous therapy when used during the first 6 weeks in the management of bone and joint infection, as assessed by treatment failure within 1 year,” Li and colleagues concluded. “Oral antibiotic therapy was associated with a shorter length of hospital stay and with fewer complications than intravenous therapy.” – by Marley Ghizzone
Disclosures: Li reports receiving grants from the National Institute for Health Research Health Technology Assessment during the conduct of the study. Please see the study for all other authors’ relevant financial disclosures.