This study was a double-blind randomized clinical study to compare the effects of dysentery cefixime and azithromycin in children. Children 6 months to 12 years as an outpatient with complaints and dysentery (diarrhea with blood and diarrhea as proven by testing) are studied refer to the pediatric clinic of Technology. Patients will be randomly divided into two groups. The first group (58 patients) received azithromycin for five days. The second group (n = 58) as well as the amount of drug cefixime will receive daily. Then all the subjects studied during 14 days of dysentery will improve. Before administration, the patient stool samples for SE (stool test) and SC (stool culture) and antibiogram will be sent to laboratories. Children who have had any underlying disease (such as malabsorption problems, a history of previous prolonged diarrhea, intestinal polyps, malnutrition, impaired immunity, use of probiotic agents, inflammatory bowel disease or chronic inflammatory disease of the small intestine) or A (during one month prior to the study) received antibiotics are not enrolled. The children during the course of antibiotics, along with other diseases or their parents are happy to continue working on the project not be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091013366N4
Registration date:2014-11-08, 1393/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cefixime and azithromycin in pediatric dysentery
Public title
Comparison of cefixime and azithromycin in pediatric dysentery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children 6 months to 12 years referred to Amir Kabir hospital pediatric clinic complaining of dysentery.
Exclusion criteria: malabsorption; previous experience prolonged diarrhea; intestinal polyps; malnutrition; history of immunodeficiency disease of the small intestine combinations of probiotics; inflammatory bowel disease; a history of antibiotic use in the past month in the course of other diseases; lack of parental consent to continue working.
Age
From 6 months old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Elmol Hoda street
City
Arak
Postal code
Approval date
2012-07-24, 1391/05/03
Ethics committee reference number
91-135-15
Health conditions studied
1
Description of health condition studied
Dysentery
ICD-10 code
A09
ICD-10 code description
Other gastroenteritis and colitis of infectious and unspecified origin
Primary outcomes
1
Description
Stool
Timepoint
On days 3, 7 and 14
Method of measurement
Stool - a stool culture
Secondary outcomes
1
Description
Antibiogram
Timepoint
On days 3, 7 and 14
Method of measurement
Experiment
Intervention groups
1
Description
The first group will receive azithromycin for five days; the first day 12 mg / kg and for the next four days 6 mg / kg .
Category
Treatment - Drugs
2
Description
Group II will receive drug cefixime 8 mg / kg daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr. Parsa Yousefi
Street address
Amir Kabir Hospital, Railway st.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpoo
Street address
Arak University of Medical Sciences, Elmol Hoda st.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Parsa Yousefi
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
Amir Kabir Hospital, Railway st.
City
Arak
Postal code
Phone
+98 86 3465 5314
Fax
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Shahram Fazelian
Position
MD, pediatric residents
Other areas of specialty/work
Street address
Amir Kabir Hospital, Railway st.
City
Arak
Postal code
Phone
+98 86 3465 5314
Fax
Email
drfazelian@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)