Noninferiority in intention-to-treat analysis; supported by complete-case, per-protocol, sensitivity analysis
THURSDAY, Jan. 31, 2019 (HealthDay News) — For patients being treated for bone or joint infection, oral antibiotics are noninferior to intravenous antibiotics, according to a study published in the Jan. 31 issue of the New England Journal of Medicine.
Ho-Kwong Li, M.B.B.S., from the Oxford University Hospitals NHS Foundation Trust in the United Kingdom, and colleagues enrolled 1,054 adults who were being treated for bone or joint infection at 26 U.K. centers. Participants were randomly assigned to receive intravenous or oral antibiotics to complete the first six weeks of therapy within seven days after surgery (or within seven days after the start of antibiotic treatment in the absence of surgery).
The researchers found that treatment failure occurred in 14.6 and 13.2 percent of patients in the intravenous and oral groups, respectively. There was a difference in the risk for definitive treatment failure within one year in the intention-to-treat analysis (oral group versus intravenous group) of −1.4 percent (90 percent confidence interval, −4.9 to 2.2; 95 percent confidence interval, −5.6 to 2.9), indicating noninferiority. This result was supported in complete-case, per-protocol, and sensitivity analyses. There was no significant between-group difference in the incidence of serious adverse events (27.7 versus 26.2 percent; P = 0.58). The intravenous group more often had catheter complications (9.3 versus 1.0 percent).
“Appropriately selected oral antibiotic therapy was noninferior to intravenous therapy when used during the first six weeks in the management of bone and joint infection,” the authors write.
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