Objectives: To compare the effect of cefotaxime and ceftriaxone on the duration of diarrhea and fever in children with dysentery. Design: A single blind randomized clinical trial. Setting and conduct: The eligible patients with complaints of fever and bloody diarrhea hospitalized in pediatrics ward of Shahid Beheshti Hospital will be enrolled into the trial. Inclusion criteria: Age of 2 months to 14 years, having active stool exam. Exclusion criteria: Severe malnutrition, immune deficiency, using of anti-diarrheal drugs. Intervention group: Intravenous infusion of cefotaxime 50 milligram per kilogram of body weight every 8 hours. Control group: Intravenous infusion of ceftriaxone 50 milligram per kilogram of body weight daily. Primary outcome: Duration of diarrhea by studying the stool chart, duration of bloody diarrhea by studying the stool chart, fever with axillary method. Secondary outcome: Duration of hospital stay through counting the days of hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102211145N18
Registration date:2017-01-08, 1395/10/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-08, 1395/10/19
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research and Technology, Kashan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of cefotaxime and ceftriaxone on the duration of diarrhea in children with dysentery
Public title
The effect of cefotaxime on improvement of pediatric dysentery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 2 months to 12 years; Having active stool exam Exclusion criteria: Severe malnutrition; Immune deficiency; Using of anti-diarrheal drugs
Age
From 2 months old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
IR.KAUMS.REC.1395.105
Health conditions studied
1
Description of health condition studied
Dysentery
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Fever
Timepoint
Every 6 hours
Method of measurement
Mercury thermometer with axillary method
2
Description
Duration of bloody diarrhea
Timepoint
Daily
Method of measurement
Stool chart
3
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Stool chart
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
At discharge
Method of measurement
Counting the days of hospitalization
Intervention groups
1
Description
Intervention group: Intravenous infusion of cefotaxime 50 mg/kg every 8 hours
Category
Treatment - Drugs
2
Description
Control group: Intravenous infusion of ceftriaxone 50 mg/kg daily