CIPROFLOXACIN for Urinary tract infection with systemic involvement|Complicated urinary tract infection|Acute pyelonephritis|Bacterial prostatitis

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Expected life expectancy shorter than 30 days"}
• {"criterion_text":"- Conditions potentially leading to infratherapeutic concentrations of peroral medication (swal-lowing difficulties, malabsorption)"}
• {"criterion_text":"- Patients participating to any other interventional UTI study"}
• {"criterion_text":"- UTI with any pathogen requiring increased ciprofloxacin dosing (750 mg bid). E.g. P. aeruginosa UTI."}
• {"criterion_text":"- Required lowered ciprofloxacin dosing (lower than 500 mg bid)."}
• {"criterion_text":"- Patients who have received active empirical treatment against the isolated bacteria in the out-patient setting for <72 h before inclusion"}
• {"criterion_text":"- 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))"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Clinical cure rate (resolution of systemic signs/symptoms to pre-admission state, no need of new antibiotic treatment), assessed 14 days after completion of antibiotic treatment.","definition_or_measurement_approach":"Clinical cure defined as resolution of systemic signs/symptoms to pre-admission state and no need for new antibiotic treatment; assessed 14 days after completion of antibiotic treatment."}

Secondary endpoints

• {"endpoint_text":"- Early UTI relapse (new UTI, caused by same uropathogen as index episode) rates: assessed 14 days after completion of treatment","definition_or_measurement_approach":"New UTI caused by same uropathogen as index episode; assessed 14 days after completion of treatment."}
• {"endpoint_text":"- Late UTI relapse rates: assessed 28 days after completion of treatment","definition_or_measurement_approach":"Late relapse assessed 28 days after completion of treatment."}
• {"endpoint_text":"- Early UTI recurrence rates (new UTI caused by a different uropathogen than that isolated during the index episode): assessed 14 days after completion of treatment","definition_or_measurement_approach":"Recurrence with a different uropathogen; assessed 14 days after completion of treatment."}
• {"endpoint_text":"- Late UTI recurrence rates: assessed 28 days after completion of treatment","definition_or_measurement_approach":"Recurrence with a different uropathogen; assessed 28 days after completion of treatment."}
• {"endpoint_text":"- UTI-related mortality rates: assessed 28 days after completion of treatment","definition_or_measurement_approach":"Mortality related to UTI; assessed 28 days after completion of treatment."}
• {"endpoint_text":"- Investigational Medical Product-related adverse drug reactions: assessed 14 days after completion of treatment","definition_or_measurement_approach":"IMP-related adverse drug reactions collected and assessed 14 days after completion of treatment."}
• {"endpoint_text":"- UTI-related hospital readmission rates: assessed 28 days after completion of treatment","definition_or_measurement_approach":"Hospital readmissions attributable to UTI; assessed 28 days after completion of treatment."}

Belgium

Earliest CTIS Part Ii Submission Date

27-04-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

15

Number Of Sites

8

Number Of Participants

264

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"Belgium","full_name":"Universitair Ziekenhuis Gent","duties_or_roles":"14","organisation_type":"Hospital/Clinic/Other health care facility"}