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Comparison of the effect of oral cotrimoxazole and topical intranasal mupirucin on staphylococcus aureus colonization in hemodialysis patients: A clinical trial

Protocol summary

Summary
The aim of this study is to compare of the effect of oral cotrimoxazole and topical intranasal mupirucin on staphylococcus aureus colonization in hemodialysis patients. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into A and B groups. Randomization will be performed using random block sizes of 4. The study is randomized, single-center, phase 3 trial. Inclusion criteria : Hemodialysis patients carriers of staphylococcus. Exclusion criteria:Patients death; patients migration. Sample size:23 patients. The intervention used in the study: Oral cotrimoxazole 400 mg twice daily for 7 days. Primary outcomes: Bacterial decolonization

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122331527N1
Registration date: 2017-02-17, 1395/11/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-17, 1395/11/29
Registrant information
Name
Ehsan Binesh
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23233390433
Email address
binesh@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shahroud University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral cotrimoxazole and topical intranasal mupirucin on staphylococcus aureus colonization in hemodialysis patients: A clinical trial
Public title
The effect of oral cotrimoxazole and topical intranasal mupirucin on staphylococcus aureus colonization in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Hemodialysis patients carriers of staphylococcus. Exclusion criteria:Patients death; patients migration
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 23
Randomization (investigator's opinion)
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, Vice chancellor for research, Shahroud University of Medical Sciences
Street address
Ethics committee, Vice chancellor for research, Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Postal code
3613773955
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IR.SHMU.REC.1394.117

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
Bacterial decolonization
Timepoint
1,4 and 12 weeks after treatment
Method of measurement
Bacterial culture

Secondary outcomes

empty

Intervention groups

1

Description
Intevention group: Oral cotrimoxazole 400 mg twice daily for 7 days
Category
Treatment - Drugs

2

Description
Control group: Topical mupirocin 2% twice daily for 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam hossein hospital
Full name of responsible person
Dr Ehsan Binesh
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue, Shahroud
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad hasan Emamian
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Shahroud 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
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Full name of responsible person
Mojgan Taleb
Position
Physician
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Towhidi avenue, Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
Email
binesh@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Full name of responsible person
Dr Ehsan Binesh
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
Email
binesh@shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Full name of responsible person
Dr Ehsan Binesh
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
Email
binesh@shmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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