Comparison of the effect of taking prophylactic antibiotics twice a week with daily in children with recurrent urinary tract infections
rate of urinary tract infections in children by taking prophylactic antibiotics every night according to age
rate of urinary tract infections by taking prophylactic antibiotics every night by sex
rate of urinary tract infections by taking prophylactic antibiotics twice a week by sex
rate of urinary tract infections by taking prophylactic antibiotics twice a week according to age
Design
Clinical trial with control group, with parallel Group, non-blind,simple sampling, phase 1 on 60 patients.
Settings and conduct
Children with vesicoureteral reflux who referred to the nephrology of Dr. Sheikh Hospital were selected and divided into control and intervention groups. In both groups, follow-up was performed for ten months. Urine test was taken from the patients on a monthly basis and the recurrence rate of urinary tract infection was evaluated by positive urine culture.
Participants/Inclusion and exclusion criteria
include criteria:
Complete the consent form to participate in the project
Children with grade 2 or higher reflux who need prophylactic antibiotics
Resident of Mashhad or nearby cities that can be followed
exclude criteria:
Dissatisfaction with continued cooperation
Migration
Patients with impaired consciousness or mental retardation
Patients cared for in orphanages
Patients with a history of urinary tract stones
History of hypersensitivity reaction to cotrimoxazole or cephalexin
Do not refer for testing
Intervention groups
In the intervention group, prophylactic antibiotics were given twice a week of cotrimoxazole at a dose of 5 mg / kg, and in the control group, prophylactic antibiotics were given a single daily dose of cephalexin.
Main outcome variables
Recurrence rate of urinary tract infection was determined by positive urine culture.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201112049368N1
Registration date:2020-12-11, 1399/09/21
Registration timing:retrospective
Last update:2020-12-11, 1399/09/21
Update count:0
Registration date
2020-12-11, 1399/09/21
Registrant information
Name
Amin Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5422 2821
Email address
amin.taheri2731@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
2015-07-23, 1394/05/01
Actual recruitment end date
2016-04-20, 1395/02/01
Trial completion date
2017-02-19, 1395/12/01
Scientific title
Comparative study of prophylactic antibiotics twice a week with antibiotics every night in recurrent urinary tract infections in children
Public title
Evaluation of various antibiotic regimens in recurrent urinary tract infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete the consent form to participate in the project
Children with grade 2 or higher reflux who need prophylactic antibiotics
Patients in good general condition
Resident of Mashhad or nearby cities that can be followed
Exclusion criteria:
Dissatisfaction with continued cooperation
Migration
Patients with impaired consciousness or mental retardation
Patients cared for in orphanages
Patients with a history of urinary tract stones
History of hypersensitivity reaction to cotrimoxazole or cephalexin
Do not refer for testing
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Mashhad University of Medical Sciences
Street address
School of Medicine, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IR.MUMS.REC.1394.298
Health conditions studied
1
Description of health condition studied
recurrent urinary tract infections
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
The recurrence rate of urinary tract infection (asymptomatic and symptomatic)
Timepoint
At the beginning of the study and then after receiving antibiotics, once a month for ten months
Method of measurement
Urine culture with more than 10 to the power of 5 colonies
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Consumption of 5 mg/kg cotrimoxazole twice a week for ten months
Category
Prevention
2
Description
Control group: Consumption of 10 mg/kg cephalexin daily for ten months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh Hospital
Full name of responsible person
Amin Taheri
Street address
Sheykh Hospital, Sheykh Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Fax
+98 51 3727 7470
Email
Sheikh.hos@mums.ac.ir
Web page address
https://sheikh.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Taheri
Street address
School of Medicine, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3804 9000
Fax
+98 51 3843 6827
Email
p.relations@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Taheri
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 17, alley 17, 72 Tan Street
City
Khaf
Province
Razavi Khorasan
Postal code
9561834465
Phone
+98 51 5422 2821
Email
amin.taheri2731@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Taheri
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 17, alley 17, 72 Tan Street
City
Khaf
Province
Razavi Khorasan
Postal code
9561834465
Phone
+98 51 5422 2821
Email
amin.taheri2731@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Taheri
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 17, alley 17, 72 Tan Street
City
Khaf
Province
Razavi Khorasan
Postal code
9561834465
Phone
+98 51 5422 2821
Email
amin.taheri2731@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD