Protocol summary

Summary
Purpose: the frequency of MRSA carriers before and after treatment in the ICU at 5th Azar Hospital, Gorgan, Iran. Design: during the first 3 months of infection caused by MRSA strains in the ICU of the hospital will be determined when all the cultures after 48 hours of hospitalization in the ICU occur. As the nosocomial infections are recorded. During this term the prevalence of methicillin resistance in Staphylococcus is determined using two methods and PCR sensitivity cefoxitin is evaluated and recorded. Three months after the end of the second stage begins. The first stage for all personnel the venice patients who from the date the part are imported. Staphylococcus aureus cultured from the nose to investigate if the person is a carrier and can be is treated with mupirocin or similar drugs. Staphylococcus aureus culture-positive All items registration for 6 months from the date of samples positive for methicillin resistance are examined. MRSA results in the comparable period of 3 months and checked by statistical tests to distinguish if whether this intervention to prevent could from incidence MRSA. Participants: personnel and patients admitted ICU ward. Intervention: mupirocin ointment. The main outcome variables: the bacteria Staphylococcus aureus, mupirocin, age, sex, type of infection, the site of infection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102519666N1
Registration date: 2014-12-19, 1393/09/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Abolfazl Khandandel
Name of organization / entity
Gorgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3223 7234
Email address
a.khandandel@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences, Research
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of diagnosis and MRSA carriers therapy in the prevention of nosocomial infection in ICU department of 5th Azar Gorgan Hospital
Public title
Performance eradication of Staphylococcus aureus with mupirocin in nasal personnel ICU ward.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients suffering from hospital infection with MRSA Staphylococcus aureus infection. Exclusion criteria: patients with kidney disease; dialysis; pregnancy and also sensitivity to drug.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, 3rd km of Sari- Gorgan Road
City
Gorgan
Postal code
Approval date
2014-05-06, 1393/02/16
Ethics committee reference number
35/658049

Health conditions studied

1

Description of health condition studied
Staphylococcus aureus infection
ICD-10 code
B95.6
ICD-10 code description
Staphylococcus aureus as the cause of diseases classified to other chapters

Primary outcomes

1

Description
Staphylococcus aureus
Timepoint
3 month before and 3 month after intervention.
Method of measurement
one coloni in culture & PCR

Secondary outcomes

empty

Intervention groups

1

Description
mupirocin pomade 2% in nasal 2 times in day for 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan 5th Azar Hospital
Full name of responsible person
Abolfazl KHandan del , MSc Microbiology
Street address
5th Azar Hospital
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences
Full name of responsible person
Dr. Masoud Khoshnia
Street address
Golestan University of Medical Sciences-esearch and Technology
City
Gorgan
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 and Technology, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Abolfazl Khandandel
Position
MSc in Microbiology
Other areas of specialty/work
Street address
5th Azar Hospital
City
Gorgan
Postal code
4917769839
Phone
+98 17 3222 0561
Fax
+98 17 3233 8875
Email
Ab.khandandel@gouma.ac.ir; ab.khandandel@gmail.com; ab.khandandel@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Ghaem Ezzat Allah
Position
Professor
Other areas of specialty/work
Street address
Golestan University of Medical Sciences
City
Gorgan
Postal code
4917769839
Phone
+98 17 3242 0651
Fax
+98 17 3233 8875
Email
eghaemi@yahii.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Abolfazl Khandandel
Position
MSc Microbiology
Other areas of specialty/work
Street address
5th Azar Hospital
City
Gorgan
Postal code
4917769839
Phone
+98 17 3223 7234
Fax
+98 71 3233 8875
Email
Ab.khandandel@gmail.com
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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