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Or v IV Antibiotics for Infection
Sponsor: Rothman Institute Orthopaedics
Summary
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.
Official title: Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2021-01-25
Completion Date
2028-01-25
Last Updated
2026-10-08
Healthy Volunteers
Yes
Conditions
Interventions
Bactrim
Bactrim will be given for 6 weeks to treat joint infection
Cefadroxil
Cefadroxil will be given for 6 weeks to treat joint infection
Doxycycline Hcl
Doxycycline HCl will given for 6 weeks to treat joint infection
Clindamycin
Clindamycin will given for 6 weeks to treat joint infection
Locations (1)
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States