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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2026-05-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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.

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 8

1. Expected life expectancy shorter than 30 days
2. Conditions potentially leading to infratherapeutic concentrations of peroral medication (swal-lowing difficulties, malabsorption)
3. Patients participating to any other interventional UTI study
4. UTI with any pathogen requiring increased ciprofloxacin dosing (750 mg bid). E.g. P. aeruginosa UTI.
5. Required lowered ciprofloxacin dosing (lower than 500 mg bid).
6. Patients who have received active empirical treatment against the isolated bacteria in the out-patient setting for <72 h before inclusion
7. 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))
8. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. Early UTI relapse (new UTI, caused by same uropathogen as index episode) rates: assessed 14 days after completion of treatment
2. Late UTI relapse rates: assessed 28 days after completion of treatment
3. 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
4. Late UTI recurrence rates: assessed 28 days after completion of treatment
5. UTI-related mortality rates: assessed 28 days after completion of treatment
6. Investigational Medical Product-related adverse drug reactions: assessed 14 days after completion of treatment
7. UTI-related hospital readmission rates: assessed 28 days after completion of treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Vitality Research Group

Public contact point

Organisation

UZ Brussel

Contact name

Vitality Research Group

Third parties 1

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications