OBJECTIVE: To compare 1 and 2-weeks of sequential intravenous and oral treatment for complicated urinary tract infection. DESIGN: Randomized, clinical trial. SETTING: 2 secondary and 1 tertiary care hospital in the Netherlands. PATIENTS: Patients (54) were randomly assigned, after 3 days Fleroxacin 400 mg iv once daily, to receive oral fleroxacin (400 mg OD,) either during 4 (total 7) days (n = 26), or during 11 (total 14) days (n = 28). Thirty-four patients were evaluable for efficacy. Complicated urinary tract infection was defined as the presence of an anatomical or functional abnormality of the urinary tract, urinary tract instrumentation, patients presenting with clinical signs and symptoms of pyelonephritis or a serious illness such as diabetes mellitus, immunosuppression or renal failure. Complicated urinary tract infection was defined as the presence of an anatomical or functional abnormality of the urinary tract, urinary tract instrumentation, patients presenting with clinical signs and symptoms of pyelonephritis or a serious illness such as diabetes mellitus, immunosuppression or renal failure. RESULTS: A bacteriological cure was seen in 22 of 34 (65%) patients at 4-6 weeks after therapy. Overall, a favorable bacteriological response was obtained in 26 of 34 (76%) patients. No significant difference could be found among the two dosage groups (7 days: 14 18 = 78 %; 14 days: 12 16 = 75 %). CONCLUSIONS: Sequential iv and oral treatment with fleroxacin in complicated UTI is a satisfactory treatment modality. Larger trials should be done in a more homogeneous population, studying shorter treatment durations in complicated UTI.
RCT Entities:
OBJECTIVE: To compare 1 and 2-weeks of sequential intravenous and oral treatment for complicated urinary tract infection. DESIGN: Randomized, clinical trial. SETTING: 2 secondary and 1 tertiary care hospital in the Netherlands. PATIENTS: Patients (54) were randomly assigned, after 3 days Fleroxacin 400 mg iv once daily, to receive oral fleroxacin (400 mg OD,) either during 4 (total 7) days (n = 26), or during 11 (total 14) days (n = 28). Thirty-four patients were evaluable for efficacy. Complicated urinary tract infection was defined as the presence of an anatomical or functional abnormality of the urinary tract, urinary tract instrumentation, patients presenting with clinical signs and symptoms of pyelonephritis or a serious illness such as diabetes mellitus, immunosuppression or renal failure. Complicated urinary tract infection was defined as the presence of an anatomical or functional abnormality of the urinary tract, urinary tract instrumentation, patients presenting with clinical signs and symptoms of pyelonephritis or a serious illness such as diabetes mellitus, immunosuppression or renal failure. RESULTS: A bacteriological cure was seen in 22 of 34 (65%) patients at 4-6 weeks after therapy. Overall, a favorable bacteriological response was obtained in 26 of 34 (76%) patients. No significant difference could be found among the two dosage groups (7 days: 14 18 = 78 %; 14 days: 12 16 = 75 %). CONCLUSIONS: Sequential iv and oral treatment with fleroxacin in complicated UTI is a satisfactory treatment modality. Larger trials should be done in a more homogeneous population, studying shorter treatment durations in complicated UTI.