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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female gender
* Age ≥ 18 years
* Written informed consent
* At least one of four key UTI symptoms that could be attributed to an uncomplicated UTI, and no alternative explanation (i.e. symptoms suggestive of STI or vulvo-vaginitis):
* Dysuria
* Urgency (including nocturia)
* Frequency
* Suprapubic tenderness
* Urine dipstick test positive for either nitrites or leukocyte esterase
* Patient is at increased risk for resistant pathogens, e.g., FQ-resistant or ESBL-producing Enterobacteriacae
Exclusion Criteria:
* Male sex
* Pregnancy or planned pregnancy
* Known carriage of nitrofurantoin- or fosfomycin-resistant uropathogens(s)
* Concomitant antimicrobial therapy
* Use of any antibiotics in the past 7 days
* Known or suspected hypersensitivity or allergy to fosfomycin or nitrofurantoin
* History of lung or liver reaction or peripheral neuropathy after use of nitrofurantoin or other nitrofurans in the past
* Pre-existing polyneuropathy
* G6PD deficiency
* Symptoms consistent with UTI in the preceding 4 weeks
* Active upper UTI (e.g. pyelonephritis, urosepsis: fever \> 38.0, flank pain, chills)
* Symptoms/signs suggestive of vaginitis or sexually transmitted infection
* Indwelling catheter, nephrostomy, ureter stent or other foreign material
* Otherwise complicated UTI:
* A history of anatomical or functional abnormalities of the urogenital tract:
* Congenital abnormalities
* Polycystic kidney disease
* Obstruction or stricture of renal pelvis, ureter or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with clinical cure, clinical failure, or indeterminate clinical response (see description below)