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; Campbell James I; Nguyen Van Minh Hoang; Tran Vu Thieu Nga; Nguyen Thi Khanh Nhu; Pham Van Minh; Cao Thu Thuy; Pham Thanh Duy; Le Thi Phuong; Ha Thi Loan; Mai Thu Chinh; Nguyen Thi Thu Thao; Nguyen Thi Hong Tham; Bui Li Mong; Phan Van Be Bay; Day Jeremy N; Dolecek Christiane; Nguyen Phu Huong Lan; To Song Diep; Farrar Jeremy J; Nguyen Van Vinh Chau; Wolbers Marcel; Baker Stephen

来源：PLoS Neglected Tropical Diseases, 2011, 5(8): e1264.

DOI：10.1371/journal.pntd.0001264

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

• 出版日期2011-8