Trials / Unknown
UnknownNCT03260010
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
- 224 (estimated)
- Sponsor
- Pro-Implant Foundation · 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fosfomycin | Infectofos 5 g |
Timeline
- Start date
- 2018-01-15
- Primary completion
- 2020-04-15
- Completion
- 2021-04-15
- First posted
- 2017-08-24
- Last updated
- 2018-04-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03260010. Inclusion in this directory is not an endorsement.