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Comparing short-course antibiotics for uncomplicated urinary tract infections in women

Clinical Effectiveness and Bacteriological Eradication of Three Different Short-course Antibiotic Regimens and Single-dose Fosfomycin for Uncomplicated Lower Urinary Tract Infections in Adult Women.

Phase 4 Interventional Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · NCT04959331

This study is testing four different short courses of antibiotics to see which one works best for treating uncomplicated urinary tract infections in women aged 18 and older.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexFemale
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Academic / other
Locations33 sites (Calatayud, Aragón and 32 other locations)
Trial IDNCT04959331 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and bacteriological eradication of four different short-course antibiotic treatments for uncomplicated lower urinary tract infections (UTIs) in women aged 18 and older. Participants will be randomly assigned to receive either a 2-day course of fosfomycin, a 3-day course of pivmecillinam, a 5-day course of nitrofurantoin, or a single dose of fosfomycin. The study will assess clinical effectiveness at day 7 and bacteriological eradication at day 14, with follow-up visits scheduled for further evaluation. A total of 1,000 patients will be enrolled, and urine samples will be collected for analysis during the follow-up visits.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 or older with symptoms of uncomplicated lower urinary tract infections and a positive urine dipstick analysis.

Not a fit: Patients with complicated urinary tract infections, such as those with pyelonephritis or other underlying conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more effective treatment options for women suffering from uncomplicated UTIs.

How similar studies have performed: While there have been studies on antibiotic treatments for UTIs, this trial is novel in its direct comparison of multiple short-course therapies against a single-dose treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Women of 18 years of age or older, with clinical features of uncomplicated community-acquired lower urinary tract infection including:

* At least one of four key symptoms of lower urinary tract infection: dysuria, urgency including nycturia, frequency, and suprapubic tenderness that could be attributed to an uncomplicated lower urinary tract infection, and no alternative explanation (i.e. symptoms suggestive of sexually-transmitted infection or vulvovaginitis), and
* A urine dipstick analysis positive for either nitrites or leukocyte esterase.

Exclusion Criteria:

* Male sex
* High suspicion of pyelonephritis (i.e. fever ≥ 37.5°C or flank pain/tenderness)
* Any condition that may lead or predispose to complicated urinary infection (i.e. indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinary tracts, recurrent urinary tract infection, severe neurological disease affecting the bladder)
* Pregnancy or planned pregnancy
* Symptoms consistent with urinary tract infection in the preceding 4 weeks
* Patients taking long-term antibiotic prophylaxis
* Ongoing antibiotic therapy or use of any systemic antibiotic in the previous 7 days
* Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain)
* Hypersensitivity or allergy to β lactams, nitrofurantoin and/or fosfomycin
* Moderate to severe chronic renal insufficiency
* Pre-existing polyneuropathy
* History of lung or liver reaction or peripheral neuropathy after previous use of nitrofurantoin
* Glucose-6-phosphate dehydrogenase deficiency
* Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionicacidaemia)
* Esophageal stricture
* Current intake of allopurinol or probenecid or valproate
* Currently part of another randomized clinical trial
* Previous enrolment in the proposed study
* Patients living in long-term institutions; and/or
* Difficulty in conducting scheduled follow-up visits

Where this trial is running

Calatayud, Aragón and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Tract InfectionsWomenPatient Outcome AssessmentBacteriological EradicationUrinalysisAnti-Bacterial AgentsAntimicrobial ResistanceShort Course
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.