Abstract | BACKGROUND: 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:
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Authors | Ha Vinh, Vo Thi Cuc Anh, Nguyen Duc Anh, James I Campbell, 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, Jeremy N Day, Christiane Dolecek, Nguyen Phu Huong Lan, To Song Diep, Jeremy J Farrar, Nguyen Van Vinh Chau, Marcel Wolbers, Stephen Baker |
Journal | PLoS neglected tropical diseases
(PLoS Negl Trop Dis)
Vol. 5
Issue 8
Pg. e1264
(Aug 2011)
ISSN: 1935-2735 [Electronic] United States |
PMID | 21829747
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Fluoroquinolones
- Ciprofloxacin
- Gatifloxacin
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Topics |
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Child, Preschool
- Ciprofloxacin
(therapeutic use)
- Dysentery, Bacillary
(blood, drug therapy, metabolism)
- Feces
(microbiology)
- Female
- Fluoroquinolones
(adverse effects, therapeutic use)
- Gatifloxacin
- Hospitals
- Humans
- Hyperglycemia
(microbiology)
- Hypoglycemia
(microbiology)
- Infant
- Male
- Proportional Hazards Models
- Shigella
(isolation & purification)
- Treatment Outcome
- Vietnam
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