A randomized controlled non-inferiority trial comparing 7 versus 14 days of ciprofloxacin for male urinary tract infections with systemic involvement.

Condition studied

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

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

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