An open-label,uncontrolled,multicenter study to evaluate the efficacy and safety of oral levofloxacin 500 mg once daily in patients with lower respiratory tract infections or urinary tract infections
Abstract
Objective To evaluate the efficacy and safety of oral levofloxacin 500 mg once daily in the treatment of patients with community acquired lower respiratory tract infections (LRTIs) or urinary tract infections (UTIs),a prospective,uncontrolled,open-label,multi-center study was conducted.Methods Patients with community acquired pneumonia (CAP),acute exacerbation of chronic bronchitis (AECB),acute uncomplicated lower urinary tract infection (LUTI),acute pyelonephritis (APN),recurrent urinary tract infection (UTI) or complicated UTI were treated by levofloxacin 500 mg tablet once daily.Results Among the 1 266 patients enrolled,1 245 were included in full analysis set (FAS) and 1 082 were included in the per protocol set (PPS).The safety analysis population was identical to the FAS population.At test of cure (day 7-14 after the end of treatment) among the PPS population,the clinical efficacy rates of CAP,AECB,LUTI,APN,recurrent UTI and complicated UTI were 96.8% (306/316),96.0% (360/375),93.7% (74/79),98.7% (76/77),94.9% (93/98) and 96.0% (24/25),respectively.The bacteriological efficacy rates were 98.4% (120/122),95.1% (136/143),97.6% (41/42),94.1% (48/51),92.3% (24/26) and 81.3% (13/16),respectively.The overall efficacy rates were 91.7% (289/315),87.2% (328/376),93.5% (72/77),89.7% (70/78),86.7% (85/98) and 69.2% (18/26),respectively.The incidence of drug-related adverse reactions (ADRs) was 17.3% (215/1 245).The most common ADRs were dizziness,nausea and insomnia.The incidence…
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