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A randomized double-blind control trial of moxifloxacin and levofloxacin in treatment of urinary tract infections

Liu Hongyu

Chinese Journal of New Drugs and Clinical Remedies, 2003

Abstract

AIM:To evaluate the efficacy and safety of moxifloxacin in the treatment of urinary tract infection. METHODS: A randomized double-blind control study (part 1) and an open label study (part 2) were conducted. In part 1, the patients in the treatment group received one moxifloxacin active tablet and one placebo tablet in the morning and two placebo tablets in the evening. The patients in the control group received two levofloxacin active tablets for 7-14 d. In part 2, the patients in the open group received one moxifloxacin active tablet po, qd for 7-14 d. RESULTS: The numbers of patients enrolled into moxifloxacin and levofloxacin group in the randomized double-blind control study and in the open study were 22, 22, 22, respectively. The numbers of patients for the efficacy analysis were 20, 20, 18, respectively. On 1 d after treatment, the clinical efficacy rates were 90 %, 95 %, 94 %, respectively; the bacterial efficacy rates were 84 %, 100 %, 100 %, respectively. Susceptibility testing showed that moxifloxacin and levofloxacin had the same high susceptibility rate and sensitivity rate, which were 82 % and 100 %, respectively. Adverse reaction rates were 23 %, 23 %, 14 % in the three groups, respectively. CONCLUSION:The results show that moxifloxacin is effective and safe in the treatment of urinary tract infection.

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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