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Fosfomycin versus drug combination for oral step‑down treatment of febrile urinary tract infections caused by E. coli in men

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

A febrile male urinary tract infection is an infection of the bladder or kidneys in men that is accompanied by fever. The infection is usually caused by the bacteria Escherichia coli. Standard treatment often includes oral antibiotics such as the fluoroquinolones class (for example, ofloxacin, levofloxacin, or ciprofloxacin) or the combination called cotrimoxazole (sulfamethoxazole plus trimethoprim). The study evaluates a different oral antibiotic, the fosfomycin‑trometamol combination, as a possible follow‑up (step‑down) therapy after initial hospital care.

The purpose of the study is to determine whether the fosfomycin regimen works at least as well as the usual antibiotics. Participants are randomly assigned to receive either the fosfomycin combination or one of the standard treatments for about twelve days. After finishing the medication, they are checked several times over the next few weeks to see if the fever has resolved, symptoms have disappeared, and no additional antibiotics are needed.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization to treatment group

    After signing the consent form, you are randomly assigned to one of two treatment options. the first option is the experimental drug fosfomycin (also called fosfomycin‑trometamol). the second option is a standard antibiotic, which may be a fluoroquinolone such as ofloxacin, levofloxacin or ciprofloxacin, or the combination drug sulfamethoxazole‑trimethoprim (also known as cotrimoxazole). the assignment is made by the study computer and you will not know which group you are in.

    The purpose of randomization is to compare the effectiveness of the experimental drug with the standard antibiotics in men who have a fever and a urinary tract infection caused by susceptible bacteria.

  2. Step 2

    Receive study medication and start treatment

    You will be given the medication that corresponds to your assigned group. the dosage is written on the medication label and explained by the study staff.

    If you are assigned to the experimental group, you will take fosfomycin 3 g (three grams) by mouth once each day for a total of 12 days.

    If you are assigned to the standard‑treatment group, you will take the prescribed fluoroquinolone (for example, ofloxacin 400 mg, levofloxacin 500 mg, or ciprofloxacin 1000 mg) or the combination sulfamethoxazole‑trimethoprim at the dose indicated by the study protocol, taken by mouth each day for 12 days. the exact number of tablets and timing (morning and evening) will be explained to you.

  3. Step 3

    Daily self‑monitoring during the 12‑day treatment

    Each day you should measure your body temperature. a temperature below 38 °C (100.4 °F) is considered normal.

    You should also note any urinary symptoms such as pain, urgency, or burning while urinating, and report if they improve or worsen.

    Do not take any other antibiotics or medicines for the infection unless you are told to do so by the study team.

    If you experience side effects such as nausea, rash, diarrhea, or any new symptoms, write them down and inform the study staff at the next visit or by the contact method provided in your study diary.

  4. Step 4

    Completion of the 12‑day medication course

    After the twelfth dose, you stop taking the study medication. keep the medication package for the study record, but do not use any leftover tablets.

  5. Step 5

    Primary evaluation on day 26

    14 days after you finish the medication (which is day 26 of the study), you return to the clinic for the primary evaluation.

    The study staff will check your temperature, ask about any remaining urinary symptoms, and verify that you have not needed any additional antibiotics.

    A urine sample may be collected to confirm that the infection has cleared.

    A rectal swab may be taken to test for the presence of antibiotic‑resistant bacteria. this helps the researchers understand if resistant bacteria are carried after treatment.

  6. Step 6

    Secondary evaluation on day 40

    28 days after the end of treatment (day 40 of the study), you attend a second follow‑up visit.

    The staff will ask whether you have had any new episodes of fever or urinary tract infection, which are recorded as a possible recurrence.

    Any additional health information since the previous visit is also collected.

  7. Step 7

    Final study completion

    After the day‑40 visit, no further study visits are required. the data you provided will be used by the researchers to compare the two treatment groups.

    You may be asked to keep a short record of any late side effects for a few weeks, but no additional clinic visits are scheduled.

Who can join the trial?

9 criteria

  • You must be a male.
  • You must be at least 18 years old.
  • Your body temperature must have been 38°C (100.4°F) or higher within the 72 hours before the urinary infection was diagnosed.
  • You must have at least one of these urinary symptoms: dysuria (painful or burning when you pee), increased need to urinate (higher urinary frequency), strong urge to urinate (urgency), hematuria (blood in the urine), pain above the bladder (suprapubic pain), pain in the prostate area (prostatic pain), pain in the side or back near the kidneys (flank pain), or pain in the area between the genitals and anus (perineal pain).
  • A urine culture (lab test of your urine) must be positive and show: the sample was taken before any antibiotics were started, at least 10 white blood cells per microliter, only one type of bacteria growing – specifically Escherichia coli (E. coli) – and a bacterial count of at least 1,000 CFU/mL (colony forming units per milliliter).
  • The bacteria must be susceptible (able to be killed) by the study drug fosfomycin and also by either fluoroquinolones (FQ) or cotrimoxazole (TMP‑SMX), according to the standards of EUCAST.
  • The bacteria must also be susceptible to the first antibiotic you received before joining the study (empiric antibiotic therapy).
  • You must be able to take medicines by mouth (oral treatment).
  • After about three days (72 ± 24 hours) of effective initial antibiotic treatment, you need to show a favorable clinical evolution, meaning your fever is gone (temperature below 38°C) and the urinary infection symptoms you had at the start are improving.

Who cannot join the trial?

16 criteria

  • Having another condition that could explain the fever (a high body temperature).
  • Having been treated for a urinary tract infection (infection of the bladder or kidneys) in the past 3 months.
  • Being likely to die within the next 3 months.
  • Having major problems with thinking or memory (known as major cognitive disorders).
  • Being in jail, under a legal guardian, or otherwise not free to make decisions.
  • Not having social security coverage.
  • Not providing written consent to join the study.
  • Already taking part in another clinical trial.
  • Having severe blood infection (septic shock) that started in the urinary system.
  • Needing a urological surgery or procedure.
  • Having abnormal shapes or devices in the urinary tract (such as certain prostheses, bladder replacements, or kidney tubes).
  • Having an indwelling urinary catheter (a tube left in the bladder) unless it was placed only for the current infection.
  • Having a bladder that does not work properly because of nerve problems (neurogenic bladder).
  • Having a weakened immune system (immunosuppression).
  • Being allergic or unable to take the study medicines (a contraindication to fosfomycin‑trometamol, fluoroquinolones, or cotrimoxazole).
  • Having very severe chronic kidney disease with an estimated glomerular filtration rate (a test of kidney function) less than 20 mL/min.
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Investigated drugs

  • Fosfomycin

    is an antibiotic taken by mouth that works by stopping bacteria from building their cell walls, which kills the infection. In this study it is the new treatment being tested to see if it works as well as other commonly used antibiotics for men with fever‑related urinary tract infections caused by certain bacteria.

  • Ofloxacin

    is a fluoroquinolone antibiotic taken by mouth. It fights bacterial infections by interfering with the bacteria’s DNA processes. In the trial it serves as one of the standard treatments used for comparison with fosfomycin.

  • Levofloxacin

    is another oral fluoroquinolone antibiotic. Like other fluoroquinolones, it attacks bacterial DNA, helping to clear infections. It is used in the study as a comparator to see how well fosfomycin works relative to this commonly prescribed drug.

  • Ciprofloxacin

    is an oral fluoroquinolone antibiotic that stops bacteria from multiplying by disrupting their DNA. It is included in the trial as one of the standard antibiotics against which the effectiveness of fosfomycin is measured.

  • Sulfamethoxazole and Trimethoprim

    (often called cotrimoxazole) is a combination of two antibiotics taken by mouth. The two drugs work together to block different steps in bacterial growth, making the infection harder for the bacteria to survive. This combination is used in the study as another standard treatment to compare with fosfomycin.

What is already known about the treatment

  • OFLOXACIN

    This medication is taken as an oral tablet of 400 mg. It is an approved antibiotic that is widely used to treat urinary tract infections and other bacterial infections. It works by blocking a bacterial enzyme called DNA gyrase, which stops the bacteria from copying their DNA. It belongs to the fluoroquinolone class of antibiotics.

  • FOSFOMYCIN

    The drug is given as a single oral dose of 3 g of fosfomycin‑trometamol powder that is dissolved in water. It is an established treatment for uncomplicated urinary tract infections and is being studied for more serious infections. It stops bacteria from building their cell wall by inhibiting the enzyme MurA, leading to bacterial death. It is classified as a phosphonic‑acid antibiotic.

  • SULFAMETHOXAZOLE AND TRIMETHOPRIM

    This combination is taken as an oral tablet containing sulfamethoxazole and trimethoprim (often with inactive ingredients like bromhexine hydrochloride and tolu balsam). It is a long‑standing, approved therapy for many urinary and respiratory infections. The two drugs work together to block two steps in the bacterial production of folic acid, which is needed for growth. It is classified as a sulfonamide‑trimethoprim combination antibiotic.

  • LEVOFLOXACIN

    The medication is administered as an oral tablet of 500 mg. It is a commonly prescribed antibiotic for urinary tract infections, respiratory infections, and skin infections. It inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication in the bacteria. It belongs to the fluoroquinolone class of antibiotics.

  • CIPROFLOXACIN

    This drug is taken as an oral tablet of 1000 mg. It is an approved broad‑spectrum antibiotic used for urinary, gastrointestinal, and respiratory infections. It works by interfering with bacterial DNA gyrase, which stops the bacteria from copying their genetic material. It is also a member of the fluoroquinolone antibiotic class.

Investigated diseases

Acute febrile urinary tract infection in males caused by Escherichia coli - This condition is an infection of the male urinary system that produces fever and is caused by the bacterium Escherichia coli. It usually begins when bacteria enter the urethra and travel upward to the bladder and sometimes the prostate. As the infection spreads, the person may feel pain or burning when urinating, feel the need to urinate often, and develop a fever. Over several days the symptoms can become more intense before they start to improve.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525972-25-00Protocol codeAPHP240801Estimated enrolment312 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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