Document Detail


Oral ciprofloxacin vs. intramuscular ceftriaxone as empiric treatment of acute invasive diarrhea in children.
MedLine Citation:
PMID:  11099086     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Acute invasive diarrhea is a potentially serious condition in children. Because of the increasing resistance of enteric pathogens to commonly used oral antibiotics, intramuscular ceftriaxone has become the routine drug in the treatment of acute invasive diarrhea requiring an emergency visit in southern Israel. The inconvenience of this parenteral regimen created an increased need for oral pediatric formulations for the treatment of invasive diarrhea. OBJECTIVES: To evaluate the efficacy and safety of a suspension formulation of ciprofloxacin in the treatment of acute invasive diarrhea in infants and children. PATIENTS AND METHODS: From July 1996 through December 1997, 201 evaluable children ages 6 months to 10 years (35% <1 year; 70% <3 years) presenting with acute invasive diarrhea at the Pediatric Emergency Room were randomized to receive either ciprofloxacin suspension (10 mg/kg twice a day + im placebo; n = 95) or im ceftriaxone (50 mg/kg/day + placebo suspension; n = 106) for 3 days in a double blind manner. Stool cultures for Shigella, Salmonella, Campylobacter spp. and diarrheagenic Escherichia coli were obtained on Days 1, 3, 4 to 5 and 21 +/- 5. Clinical response and safety were assessed on Days 1, 2, 3, 4 to 5 and 21 +/- 5. RESULTS: We isolated 127 pathogens from 121 (60%) patients: 73 (57%) Shigella; 23 (18%) Salmonella; 18 (14%) E. coli; and 13 (10%) Campylobacter. Overall bacteriologic eradication on Day 4 to 5 was 99% for Shigella, 77% for Salmonella and 77% for Campylobacter, with no difference between the 2 groups. Clinical cure or improvement was observed in 100 and 99% of the ciprofloxacin and ceftriaxone groups, respectively. Serum ciprofloxacin values determined on Day 3 of the treatment were higher in the majority of patients than were the MIC50 and MIC90 values for the Shigella and Salmonella spp. isolated. Possible drug-related adverse events occurred in 13 patients [ciprofloxacin, 8 (8%); ceftriaxone, 5 (4.7%)] and were mild and transient. Joint examination was normal during and after completion of therapy in all patients. CONCLUSION: Oral ciprofloxacin was as safe and effective as intramuscular ceftriaxone for the empiric treatment of acute invasive diarrhea in ambulatory pediatric patients requiring an emergency room visit.
Authors:
E Leibovitz; J Janco; L Piglansky; J Press; P Yagupsky; H Reinhart; I Yaniv; R Dagan
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  19     ISSN:  0891-3668     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  2000 Nov 
Date Detail:
Created Date:  2001-03-06     Completed Date:  2001-05-31     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1060-7     Citation Subset:  IM    
Affiliation:
Pediatric Infectious Disease Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. eugenel@bgumail.ac.il
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Administration, Oral
Adolescent
Anti-Infective Agents / therapeutic use*
Ceftriaxone / administration & dosage,  adverse effects,  therapeutic use*
Cephalosporins / therapeutic use*
Child
Child, Preschool
Ciprofloxacin / adverse effects,  blood,  therapeutic use*
Diarrhea / drug therapy*
Double-Blind Method
Female
Humans
Infant
Infant, Newborn
Injections, Intramuscular
Male
Prospective Studies
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 0/Cephalosporins; 73384-59-5/Ceftriaxone; 85721-33-1/Ciprofloxacin
Comments/Corrections
Comment In:
Pediatr Infect Dis J. 2001 Aug;20(8):817-8   [PMID:  11734755 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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