title: A multi-center randomized trial to assess the efficacy of gatifloxacin versus ciprofloxacin for the treatment of shigellosis in Vietnamese children.
abstract: 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.
  
  
  RESULTS
  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.
authors.affiliation: The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
authors.forename: Ha
authors.initials: H
authors.lastname: Vinh
authors.forename: Vo Thi Cuc
authors.initials: VT
authors.lastname: Anh
authors.forename: Nguyen Duc
authors.initials: ND
authors.lastname: Anh
authors.forename: James I
authors.initials: JI
authors.lastname: Campbell
authors.forename: Nguyen Van Minh
authors.initials: NV
authors.lastname: Hoang
authors.forename: Tran Vu Thieu
authors.initials: TV
authors.lastname: Nga
authors.forename: Nguyen Thi Khanh
authors.initials: NT
authors.lastname: Nhu
authors.forename: Pham Van
authors.initials: PV
authors.lastname: Minh
authors.forename: Cao Thu
authors.initials: CT
authors.lastname: Thuy
authors.forename: Pham Thanh
authors.initials: PT
authors.lastname: Duy
authors.forename: Le Thi
authors.initials: le T
authors.lastname: Phuong
authors.forename: Ha Thi
authors.initials: HT
authors.lastname: Loan
authors.forename: Mai Thu
authors.initials: MT
authors.lastname: Chinh
authors.forename: Nguyen Thi Thu
authors.initials: NT
authors.lastname: Thao
authors.forename: Nguyen Thi Hong
authors.initials: NT
authors.lastname: Tham
authors.forename: Bui Li
authors.initials: BL
authors.lastname: Mong
authors.forename: Phan Van Be
authors.initials: PV
authors.lastname: Bay
authors.forename: Jeremy N
authors.initials: JN
authors.lastname: Day
authors.forename: Christiane
authors.initials: C
authors.lastname: Dolecek
authors.forename: Nguyen Phu Huong
authors.initials: NP
authors.lastname: Lan
authors.forename: To Song
authors.initials: TS
authors.lastname: Diep
authors.forename: Jeremy J
authors.initials: JJ
authors.lastname: Farrar
authors.forename: Nguyen Van Vinh
authors.initials: NV
authors.lastname: Chau
authors.forename: Marcel
authors.initials: M
authors.lastname: Wolbers
authors.forename: Stephen
authors.initials: S
authors.lastname: Baker
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000627:therapeutic use*; D004405:Dysentery, Bacillary / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D005243:Feces / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000627:therapeutic use*; D000077734:Gatifloxacin; D006761:Hospitals; D006801:Humans; D006943:Hyperglycemia / Q000382:microbiology; D007003:Hypoglycemia / Q000382:microbiology; D007223:Infant; D008297:Male; D016016:Proportional Hazards Models; D012760:Shigella / Q000302:isolation & purification*; D016896:Treatment Outcome; D014744:Vietnam
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D002939:Ciprofloxacin; D000077734:Gatifloxacin