NCT05211011

Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection

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")

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Prosthetic Joint Infection

Interventions

Type	Name	Description
DRUG	Fosfomycin	Infectofos 5 g

Timeline

• Start date: 2018-01-23
• Primary completion: 2022-04-30
• Completion: 2023-04-30
• First posted: 2022-01-27
• Last updated: 2022-01-27

Locations

16 sites across 1 country: Germany