Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous
(IV) antibiotics after surgical treatment. However, there is little evidence to suggest that
oral (PO) therapy results in worse outcomes. This study aims to determine whether or not PO
antibiotics are non-inferior to IV antibiotics in treating PJI. The study is a multicenter,
parallel-group, randomized (1 : 1), open-label, non-inferiority trial. The non-inferiority
margin will be set at 10%. Adults with a clinical diagnosis of PJI according to the
International Consensus Meeting (ICM) criteria who would ordinarily receive at least 6 weeks
of antibiotics and have received ≤ 7 days of IV therapy from surgery will be included. A
total of 308 participants will be centrally computer-randomized to PO or IV antibiotics to
complete the first 6 weeks of therapy. Follow-on PO therapy will be permitted in either arm.
The primary outcome is the proportion of participants experiencing treatment failure within 1
year. An associated cost-effectiveness evaluation including complications, resource
utilization and quality-of-life data will be performed.