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Which UTI antibiotic works best? new study compares four options

NCT ID NCT04959331

Disease control Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested four different short antibiotic courses in 1,000 women with uncomplicated lower urinary tract infections. Participants received either a two-day course of fosfomycin, a three-day course of pivmecillinam, a five-day course of nitrofurantoin, or a single dose of fosfomycin. The goal was to see which treatment best relieved symptoms and cleared bacteria from the urine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fosfomycin, nitrofurantoin, pivmecillinam
What this could lead to
If successful, this could identify the most effective short-course antibiotic for uncomplicated UTIs, reducing treatment duration and side effects.
What could go wrong
This is a completed Phase 4 trial, so results are already in. However, findings may not apply to complicated UTIs or men, and antibiotic resistance could limit real-world effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,000 people

The number who actually took part.

Started

Nov 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial urinary tract infection urinary tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary tract infections

Contacts and locations

Locations

  • 17 de Setembre Center

    el Prat de Llobregat, Catalonia, 08820, Spain

  • Aquitania Health Center

    Madrid, Madrid, 28032, Spain

  • Arrabal Health Center

    Zaragoza, Aragon, 50015, Spain

  • Banyoles Center

    Banyoles, Catalonia, 17820, Spain

  • Buenos Aires Center

    Madrid, Madrid, 28038, Spain

  • Calatayud Center

    Calatayud, Aragon, 50300, Spain

  • Camp Redó Health Center

    Palma de Mallorca, Balearic Islands, 07010, Spain

  • Can Serra Center

    L'Hospitalet de Llobregat, Catalonia, 08906, Spain

  • Can Vidalet Center

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Corbera Center

    Corbera de Llobregat, Catalonia, 08757, Spain

  • El Puerto Center

    Coslada, Madrid, 28821, Spain

  • Emili Darder Center

    Palma de Mallorca, Balearic Islands, 07007, Spain

  • Florida Center

    L'Hospitalet de Llobregat, Catalonia, 08905, Spain

  • Jaume I Health Center

    Tarragona, Catalonia, 43005, Spain

  • La Gavarra Health Center

    Cornellà de Llobregat, Catalonia, 08940, Spain

  • Las Fuentes Center

    Zaragoza, Aragon, 50002, Spain

  • Los Alpes Health Center

    Madrid, Madrid, 28022, Spain

  • Mar Báltico Center

    Madrid, Madrid, 28033, Spain

  • Molí Nou Center

    Sant Boi de Llobregat, Catalonia, 08830, Spain

  • Montblanc Center

    Montblanc, Catalonia, 43400, Spain

  • Parque Goya Health Center

    Zaragoza, Aragon, 50018, Spain

  • Pere Garau Center

    Palma de Mallorca, Catalonia, 07007, Spain

  • San Fernando Health Center

    San Fernando de Henares, Madrid, 28830, Spain

  • Sant Feliu de Guíxols Center

    Sant Feliu de Guíxols, Catalonia, 17220, Spain

  • Sant Just Desvern Center

    Sant Just Desvern, Catalonia, 08960, Spain

  • Santa Clara Center

    Girona, Catalonia, 17001, Spain

  • Santa Maria del Camí Center

    Santa Maria del Camí, Balearic Islands, 07320, Spain

  • Santa Ponça Health Center

    Calvià, Balearic Islands, 07180, Spain

  • Son Pisà Center

    Palma de Mallorca, Balearic Islands, 07011, Spain

  • Son Serra-La Vileta Health Center

    Palma de Mallorca, Balearic Islands, 07013, Spain

  • Valleaguado Health Center

    Coslada, Madrid, 28823, Spain

  • Vila Vella Center

    Sant Vicenç dels Horts, Catalonia, 08620, Spain

  • Villarejo de Salvanés Health Center

    Villarejo de Salvanés, Madrid, 28590, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.