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Joint InfectionBones and jointsDrugPhase 3

What this study is

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.

What's being tested

  • Bactrim

    Intervention · DRUG

    Bactrim will be given for 6 weeks to treat joint infection

  • Cefadroxil

    Intervention · DRUG

    Cefadroxil will be given for 6 weeks to treat joint infection

  • Doxycycline Hcl

    Intervention · DRUG

    Doxycycline HCl will given for 6 weeks to treat joint infection

  • Clindamycin

    Intervention · DRUG

    Clindamycin will given for 6 weeks to treat joint infection

Study details

Official title
Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
Sponsor
Rothman Institute Orthopaedics
Conditions
Joint Infection
Enrolling
308 people
Starts
2021-01-25
Est. completion
2028-01-25
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗