A Phase 4 interventional study of nitrofurantoin and fosfomycin in Urinary Tract Infections and Cystitis, sponsored by University Hospital, Geneva. Status unknown at 3 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-02.
Sponsored by University Hospital, Geneva · Phase 4, Interventional, and Treatment
Developed before the establishment of a structured process for drug assessment, nitrofurantoin is now being prescribed frequently given the rise in multi-resistant gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness and better define the side effect profiles of both nitrofurantoin and fosfomycin. This multi-center open trial will randomize 600 non-pregnant women at three international sites (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and 28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up.
Developed before the establishment of a structured process for drug assessment, nitrofurantoin is now being prescribed frequently given the rise in multi-resistant gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness and better define the side effect profiles of both nitrofurantoin and fosfomycin. From autumn 2013 through summer 2016, this multi-center open trial will randomize 600 non-pregnant women at three international sites (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and 28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up.
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's planned enrollment of 600 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University Hospital, Geneva is the lead sponsor of 378 studies on the registry; 69 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:
Nitrofurantoin will be given orally at a dose of 100 mg three times daily for 5 days.
Drug: nitrofurantoin
A single 3g dose of oral fosfomycin will be given.
Drug: fosfomycin
nitrofurantoin 100 mg po tid for 5 days
Also known as: Macrodantin, Furadantine
fosfomycin 3g po single dose
Also known as: Monuril
Number of participants with clinical cure, clinical failure, or indeterminate clinical response (see description below)
Clinical response is defined as either (1) clinical cure, which in turn is defined as complete resolution of symptoms with no recurrence of symptoms or signs of urinary tract infection; (2) clinical failure, defined as the need for additional, or change in, antibiotic treatment due to a urinary tract infection, OR discontinuation due to lack of efficacy; or (3) indeterminate response, defined as either persistence of symptoms without objective evidence of infection (absence of bacteriuria or pyuria) OR any extenuating circumstances precluding a classification or clinical cure/failure.
Time frame: at 28 days post therapy completion
Number of participants with bacteriologic cure and with bacteriologic recurrence
Bacteriologic response is defined as either (1) bacteriologic cure, that is, eradication of the infecting strain with no recurrence of bacteriuria (\<10x3 cfu/mL) during follow-up; or (2) bacteriologic recurrence, defined as bacteriuria \>10x3 cfu/mL. However, bacteriologic recurrence without urinary tract symptoms will be designated asymptomatic bacteriuria and left untreated.
Time frame: at 28 days post therapy completion
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: within 28 days post therapy completion
Started Oct 2013 (actual). Primary completion is estimated for May 2017, 43 months after the start.
Of 43 non-industry phase 4 interventional studies under Urinary Tract Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 43 months is above that.
Counting every sponsor, half of 51 studies reached it within 30 months; a quarter within 20 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2017. 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 drugs tested here: Nitrofurantoin · Fosfomycin