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Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection — PROOF  

Prosthetic Joint Infection Clinical Trial

Official title:
Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection (PJI) Caused by Staphylococci, Streptococci, Enterococci and Gram-negative Bacilli, Including Mixed Infections and Culture Negative PJI's ("PROOF-Study")

Clinical Trial Summary

The PROOF Study is an open prospective interventional non-randomized study which aim is to determine the outcome / effect and safety of fosfomycin in patients with hip, knee or shoulder PJI.

Clinical Trial Description

To confirm a non-inferior effect and the safety of the investigated antimicrobial fosfomycin regimen in PJI of the hip, knee or shoulder against an assumed 80% effect (PJI-free proportion within one year for standard antibiotics aside fosfomycin), following a standardized surgical therapy involving retention, one-stage exchange or two-stage exchange (with short or long interval). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03260010
Study type Interventional
Source Pro-Implant Foundation
Contact Alessandra Bardelli, MSCPH, MScAC
Phone (+49) 030 450 652416
Email alessandra-catalina.bardelli@charite.de
Status Recruiting
Phase Phase 4
Start date January 15, 2018
Completion date April 15, 2021
View Details
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