A Multi-Center Randomized Trial to Assess the Efficacy of Gatifloxacin versus Ciprofloxacin for the Treatment of Shigellosis in Vietnamese Children

作者: Ha Vinh , Vo Thi Cuc Anh , Nguyen Duc Anh , James I Campbell , Nguyen Van Minh Hoang

DOI: 10.1371/JOURNAL.PNTD.0001264

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摘要: Background: The bacterial genus Shigella is the leading cause of dysentery. There have been significant increases in proportion isolated that demonstrate resistance to nalidixic acid. While acid no longer considered as a therapeutic agent for shigellosis, fluoroquinolone ciprofloxacin current recommendation World Health Organization. Resistance marker reduced susceptibility older generation fluoroquinolones, such ciprofloxacin. We aimed assess efficacy gatifloxacin versus treatment uncomplicated shigellosis children.Methodology/Principal Findings: conducted randomized, open-label, controlled trial with two parallel arms at hospitals southern Vietnam. study was designed superiority and children dysentery meeting inclusion criteria were invited participate. Participants received either (10 mg/kg/day) single daily dose 3 days or (30 divided doses days. primary outcome measure failure; secondary measures time cessation individual symptoms. Four hundred ninety four patients randomized receive (n = 249) 245), which 107 had positive stool culture. could not observed similar clinical failure rate both groups (gatifloxacin; 12.0% ciprofloxacin; 11.0%, p 0.72). median (inter-quartile range) from illness onset all symptoms 95 (66-126) hours recipients 93 (68-120) (Hazard Ratio [95%CI] 0.98 [0.82-1.17], 0.83).Conclusions: conclude Vietnam, where resistant Shigellae are highly prevalent, similarly effective acute shigellosis.

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