Objectives: To compare the effect of ciprofloxacin and ceftriaxone on the duration of diarrhea and fever in patients with dysentery. Design: A single blind randomized clinical trial. Setting and conduct: The eligible patients with complaints of fever and bloody diarrhea hospitalized in infectious diseases ward of Shahid Beheshti Hospital will be enrolled into the trial. Inclusion criteria: Age of 18 to 75 years, having active stool exam. Exclusion criteria: Severe malnutrition, immune deficiency, using of anti-diarrheal drugs. Intervention group 1: Intravenous infusion of ceftriaxone 1 gram every 12 hours for 5 days. Intervention group 2: Intravenous infusion of ciprofloxacin 400 milligram every 12 hours for 5 days. 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:IRCT2015061117985N2
Registration date:2015-06-24, 1394/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-24, 1394/04/03
Registrant information
Name
Alireza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of ciprofloxacin and ceftriaxone on the duration of diarrhea in patients with dysentery
Public title
The comparison of ciprofloxacin and ceftriaxone on improvement of dysentery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 70 years; Having active stool exam Exclusion criteria: Severe malnutrition; Immune deficiency; Using of anti-diarrheal drugs
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
2015-06-10, 1394/03/20
Ethics committee reference number
IR.KAUMS.REC.1394.43
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 1: Intravenous infusion of ceftriaxone 1 gr every 12 hours for 5 days
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous infusion of ciprofloxacin 400 mg every 12 hours for 5 days