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ENROLLING BY INVITATION
NCT04723940
PHASE3

Or v IV Antibiotics for Infection

Sponsor: Rothman Institute Orthopaedics

View on ClinicalTrials.gov

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

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

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States