A Phase 3 interventional study of Fosfomycin-trometamol and Reference treatments in Prostatitis and Escherichia Coli Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The fosfomycin-trometamol (FT) combination demonstrates microbiological efficacy against the vast majority of Escherichia coli strains responsible for urinary tract infections (UTIs). Moreover, approximately 99% of strains exhibiting multidrug resistance remain suceptible to fosfomycin.
The clinical tolerance profile of this molecule is excellent and has been well established since its market authorization in 1989 for the treatment of cystitis in women.
Its pharmacokinetic and pharmacodynamic properties are compatible with its use in the treatment of UTIs in men.
However, the clinical efficacy of FT (oral fosfomycin) in the treatment of febrile UTIs in men has never been evaluated in prospective trials. FT could represent an innovative treatment option in such cases, offering the use if an antibiotic with significantly fewer side effects than those currently recommended.
The main objective of the trial is to demonstrate that FT is not inferior to fluoroquinolones (FQ) or cotrimoxazole (TMP-SMX) as oral step-down therapy in prostatitisfebrile male urinary tract infections caused by Escherichia coli.
89 studies on the registry are indexed under Prostatitis; 12 are open to participants now.
This study's planned enrollment of 312 is above the median of 61 across 74 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 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.
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.
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.
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.
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.
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.
Drug: Fosfomycin-trometamol
Drug: Reference treatments
Oral dose : 3g Fosfomycin-trometamol once daily
Reference treatments will bet hose recommended by the French SPLIF guidlines : * Oral FQ : three molecules are authorized ; ofloxacin, ciprofloxacin and levofloxacin * TMP-SMX
Clinical cure
Defined as body temperature \< 38°C and absence of urinary tract infection symptoms, without the need for additional antibiotic therapy up to the primary evaluation on Day 26, which corresponds to 14 days after completion of a 12-day antibiotic treatment assigned by randomization.
Time frame: At day 26
Cumulative incidence of infectious and urological complications
Time frame: Up to day 40
Adherence to treatment
Time frame: Up to day 40
Occurence of adverse events related to anticiotics
Occurrence, nature, and severity of adverse events
Time frame: Up to day 40
Rectal carriage of phenotypically antibiotic-resistant Enterobacterales
Carriage of Enterobacterales resistant to FQ, TMP-SMX, fosfomycin, and third-generation cephalosporins on Day 26, i.e., 14 days after completion of the randomized antibiotic treatment Binary outcome
Time frame: At day 26
Rates of recurrence of febrile or non-febrile UTIs (relapse or reinfection)
Assessed on Day40, i.e., 28 days after completion of the randomized antibiotic treatment * UTI : reappearance of urinary symptoms with a positive urine culture (ECBU) * Febrile UTI : fever or urinary origin with a positive urine culture * Relapse : new infection caused by the same bacteria than as the initial episode * Reinfection : new infection caused by a different bacteria than the initial episode
Time frame: At day 40
Number of patients who experienced treatment failure
Clinical and biological characteristics of patients who experienced treatment failure compared to those who were cured during the initial episode
Time frame: Up to day 40
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fosfomycin
Assistance Publique - Hôpitaux de Paris →