drugset / Trial / NCT04297592
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
RandomizedParallel-groupOpen-labelPrevention
Summary
To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.
Timeline
- Start
- 2020-06-11
- Primary completion
- 2027-01
- Completion
- 2028-01
Publications
- Background Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.
- Background Li B, Webster TJ. Bacteria antibiotic resistance: New challenges and opportunities for implant-associated orthopedic infections. J Orthop Res. 2018 Jan;36(1):22-32. doi: 10.1002/jor.23656. Epub 2017 Aug 11.
- Background Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | 500 mg | Oral |
| Comparator | Cefadroxil | Small molecule | 500 mg | Oral |
| Comparator | Doxycycline | Small molecule | 100 mg | Oral |