Authorised Therapeutic confirmatory (Phase III) Urinary tract infection with systemic involvement (UTI: definite, probable, or possible UTI according to the diagnostic criteria of the research reference standard for UTI proposed by Bilsen et al (see reference 19 in protocol)). Systemic involvement: one or more of the following, attributable to the UTI: • Temperature ≥38°C • Flank pain or costovertebral angle tenderness • Systolic blood pressure <90 mmHg without alternative cause • Significant elevation of inflammatory markers related to the UTI: o C-reactive protein concentration ≥50 mg/L, Procalcitonin concentration ≥0·5 ng/mL or white blood cell count ≥12×10^9 per L (all without other plausible source, based on at least history and examination). • Bacteraemia with the same pathogen as isolated from urine culture

Shorter versus longer antibiotic treatment for serious urinary tract infections in men

EU CTIS ID: 2025-524703-76-00

What this study is testing

To demonstrate non-inferiority of a short-course ciprofloxacin strategy (≥4 days ciprofloxacin, total 7 days) versus 14 days in achieving clinical cure in male UTI with systemic involvement.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male patients aged 18 years or older
  • Urinary tract infection with systemic involvement
  • Monobacterial UTI
  • UTI empirically treated with any of the approved antibiotic regimens (see protocol)
  • Ciprofloxacin-sensitive uropathogen
  • Haemodynamically stable at inclusion, meaning no sepsis/septic shock (according to the sepsis-3 criteria)

You likely can't join if

  • Expected life expectancy shorter than 30 days
  • Conditions potentially leading to infratherapeutic concentrations of peroral medication (swal-lowing difficulties, malabsorption)
  • Patients participating to any other interventional UTI study
  • UTI with any pathogen requiring increased ciprofloxacin dosing (750 mg bid). E.g. P. aeruginosa UTI.
  • Required lowered ciprofloxacin dosing (lower than 500 mg bid).
  • Patients who have received active empirical treatment against the isolated bacteria in the out-patient setting for <72 h before inclusion
See the full eligibility criteria
Who can join
  • Male patients aged 18 years or older
  • Urinary tract infection with systemic involvement
  • Monobacterial UTI
  • UTI empirically treated with any of the approved antibiotic regimens (see protocol)
  • Ciprofloxacin-sensitive uropathogen
  • Haemodynamically stable at inclusion, meaning no sepsis/septic shock (according to the sepsis-3 criteria)
What rules you out
  • Expected life expectancy shorter than 30 days
  • Conditions potentially leading to infratherapeutic concentrations of peroral medication (swal-lowing difficulties, malabsorption)
  • Patients participating to any other interventional UTI study
  • UTI with any pathogen requiring increased ciprofloxacin dosing (750 mg bid). E.g. P. aeruginosa UTI.
  • Required lowered ciprofloxacin dosing (lower than 500 mg bid).
  • Patients who have received active empirical treatment against the isolated bacteria in the out-patient setting for <72 h before inclusion
  • Absolute contra-indication for ciprofloxacin use (known hypersensitivity to ciprofloxacin, concomitant tizanidine use, known G6PDH-deficiency, history of tendon disorders due to any fluoroquinolone, long Qtc (>450 ms, excepted from reassuring cardiology advice), history of psychiatric side effects related to fluoroquinolone use or known myasthenia gravis))
  • Following functional/anatomical urinary tract abnormalities or complicating factors: Patients presenting with indwelling urinary catheters (placement of urinary catheters during after randomization will be tolerated), kidney cyst infection, epididymitis or orchitis, kidney transplant infection, encrusted pyelonephritis, urinary tract derivation, undrained urinary tract abscedation, chronic prostatitis, permanent renal replacement therapy or glomerular filtration rate ≤20 ml/minute

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.