A Phase 4 interventional study of Fosfomycin in Prosthetic Joint Infection, sponsored by Pro-Implant Foundation. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by Pro-Implant Foundation · Phase 4, Interventional, and Treatment
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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.
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).
Pro-Implant Foundation is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For culture positive PJI's at least one of the following isolates:
staphylococci (fosfomycin MHK ≤ 32 mg/ml), streptococci (MHK ≤ 128 mg/ml), enterococci (MHK ≤ 128 mg/ml), fosfomycin susceptible gram-negative bacilli, including also mixed infections with other pathogens (fosfomycin susceptible or not);
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Include intravenous fosfomycin in the treatment of PJI according to predetermined algorithm
Drug: Fosfomycin
Infectofos 5 g
Infection cure rate
Proportion of patients free of PJI relapse (i.e. infection cure rate) within 1 year after inclusion. Relapse is defined as new PJI diagnosis more than 4 weeks after the last surgical intervention of the initial 12 week treatment period.
Time frame: 1 year
Infection cure rate
Proportion of patients free of Prosthetic Joint-Infection relapse (infection cure rate) within 2 years after inclusion
Time frame: 2 years
Proportion of patients with revision
Proportion of patients with revision (surgical intervention with or without prosthesis removal \>4 weeks after last surgical intervention of the initial 12 week treatment period)
Time frame: 1 year
Proportion of patients with revision due to hematogenous versus non-hematogenous infection
Proportion of patients with revision due to hematogenous (acute onset with duration of symptoms \<3 weeks and onset of symptoms is \>3 months after last surgery) versus non-hematogenous infection
Time frame: 1 year
Proportion of patients with unscheduled early revisions
Proportion of patients with unscheduled early revisions (\<4 weeks after last scheduled surgical intervention - deep (= bone/joint) revision versus superficial (= skin-soft tissue) revision)
Time frame: 1 year
Proportion of patients with aseptic revision
Proportion of patients with aseptic revision
Time frame: 1 year
Proportion of patients with implant failure
Proportion of patients with implant failure (any functionally affected or pain producing implant, clinically relevant abnormal laboratory test result indicating PJI, or presence of radiological signs of loosening, according to the investigator (Yes/No))
Time frame: 1 year
Proportion of patients with treatment failure
Proportion of patients with treatment failure (insufficient primary therapy or PJI relapse)
Time frame: 1 year
Proportion of patients with initially sufficient versus insufficient primary therapy
Proportion of patients with initially sufficient versus insufficient primary therapy (defined by the judgement of the investigator, based on combined clinical, laboratory, microbiological and radiological criteria, e.g. clear reduction of wound secretion)
Time frame: 1 year
Specific functional joint scores
Development and changes vs baseline of specific functional joint scores
Time frame: 1 year
EQ5D5L
EQ5D5L (in particular for 1 year follow up)
Time frame: 1 year
Safety and tolerability of fosfomycin (frequency of adverse events)
Safety and tolerability of fosfomycin will be evaluated by measuring the frequency of adverse events, including potential side effects
Time frame: 1 year
Pharmacokinetic profile of fosfomycin in plasma
Pharmacokinetic profile of fosfomycin in plasma (steady state after a single application per patient): Cmax
Time frame: 1 year
Pharmacokinetic profile of fosfomycin in plasma
Pharmacokinetic profile of fosfomycin in plasma (steady state after a single application per patient): Tmax
Time frame: 1 year
Pharmacokinetic profile of fosfomycin in plasma
Pharmacokinetic profile of fosfomycin in plasma (steady state after a single application per patient): Cmin 8 h
Time frame: 1 year
Pharmacokinetic profile of fosfomycin in plasma
Pharmacokinetic profile of fosfomycin in plasma (steady state after a single application per patient): t1/2
Time frame: 1 year
Pharmacokinetic profile of fosfomycin in plasma
Pharmacokinetic profile of fosfomycin in plasma (steady state after a single application per patient): AUC0-8
Time frame: 1 year
Pharmacokinetic profile of fosfomycin in plasma
Pharmacokinetic profile of fosfomycin in plasma (steady state after a single application per patient): extrapolated AUC0-24
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Apr 2020, 27 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fosfomycin
Pro-Implant Foundation