NCT04723940

Or v IV Antibiotics for Infection

Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Joint Infection

Interventions

Type	Name	Description
DRUG	Bactrim	Bactrim will be given for 6 weeks to treat joint infection
DRUG	Cefadroxil	Cefadroxil will be given for 6 weeks to treat joint infection
DRUG	Doxycycline Hcl	Doxycycline HCl will given for 6 weeks to treat joint infection
DRUG	Clindamycin	Clindamycin will given for 6 weeks to treat joint infection

Timeline

• Start date: 2021-01-25
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2021-01-26
• Last updated: 2021-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study