Objectives: The aim of this clinical trial study was to compare the effects of co-trimoxazole and co-trimoxazole plus ciprofloxacin for prophylaxis of urinary tract infection(UTI) in renal transplant recipients. Design: This clinical trial was carried out from 2014 to 2015 in Al-Zahra Hospital of Esfahan, Iran. The target population was patients undergoing kidney transplant in the center. Setting and conduct: The target population consists of 50 patients undergoing kidney transplantation and divided into two groups of 25 using block randomization. Participants including major eligibility criteria: The inclusion criteria include age over 18 years; the recipient of kidney transplant and the exclusion criteria also include concurrent use of other antibiotics in the course of investigation and withdrawal from the study. Intervention: In Group I, co-trimoxazole was administered with a daily dose of 160/800 mg for a period of six months as in standard protocol. In Group II, co-trimoxazole was administered daily for six months along with 250 mg ciprofloxacin every 12 hours for the first one month. The patients were followed at one, three, and six months after renal transplantation, and were treated in case of UTI. Main outcome measures: Questionnaires included the incidence and the time of developing of UTI after transplantation.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015120823743N1
Registration date:2015-12-23, 1394/10/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Farzin Khorvash
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 313792900698
Email address
khorvash@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Isfahan University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of co-trimoxazole and co-trimoxazole plus ciprofloxacin in urinary tract infection prophylaxis in kidney transplant patients
Public title
Prophylaxis of urinary tract infection(UTI)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; Consent to inclusion; The recipient of kidney transplant; Lack of recent urinary infection; Lack of Glucose 6 Phosphate Dehydrogenase(G6PD); No prior consumption of antibiotic.
Exclusion criteria: Inaccessibility to the patient to determine various causes of urinary infection such as death or migration; Concurrent use of other antibiotics in the course of investigation; Withdrawal from the study; Allergic reaction to medications; Drug intolerance.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.mui.rec.1394.3.264
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
B99,B99
ICD-10 code description
Other infectious diseases
Primary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
2
Description
-
Timepoint
-
Method of measurement
-
3
Description
Urinary tract infection
Timepoint
1,3and 6 months after intervention
Method of measurement
Questionnaire, urine analysis and urine culture
4
Description
The time of developing urinary tract infection after kidney transplant
Timepoint
1,3 and 6 months after intervention
Method of measurement
Questionnaire, urine analysis and urine culture
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
2
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 1:In Group I, co-trimoxazole was administered with a daily dose of 160/800 mg for a period of six months as in standard protocol. (company Rose daroo)
Category
Treatment - Drugs
2
Description
Intervention group 2: In Group II, co-trimoxazole was administered daily for six months along with 250 mg ciprofloxacin every 12 hours for the first one month. Cotrimoxazole from Rose daroo company and ciprofloxacine from Farabi company
Category
Treatment - Drugs
3
Description
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Isfahan
Full name of responsible person
Atousa Hakamifard
Street address
Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Alzahra Hospital of Isfahan
Full name of responsible person
Atousa Hakamifard
Street address
Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
3
Recruitment center
Name of recruitment center
Alzahra Hospital of Isfahan
Full name of responsible person
Atousa Hakamifard
Street address
Alzahra Hospital, Soffeh Avenue, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
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
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant, infectious diseases and tropical medicine research center
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Phone
+98 31 3233 4553
Fax
Email
Atousa_medline@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant, infectious diseases and tropical medicine research center
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3233 4553
Fax
Email
Atousa_medline@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant, infectious diseases and tropical medicine research center
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3233 4553
Fax
Email
Atousa_medline@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)