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

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

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.

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

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