Protocol summary

Summary
The aim of this study is study of Mupirocin effect on Nasal Staph aureus decolonization and prevention of Intensive Care Unit infection, by Nasal aureus .In this, Randomized Clinical Trail, Nasal swab will be taken from nose of all patients have been admitted to Intensive Care Unit ward within 48 hours after admission. The swab microbiologically investigate for the presence of S.aureus. Based on the result of nasal swabs patients will be divided to three groups: First, those patients whom are negative for S.aureus. This group will be followed up during the time of hospitalization. Secondly, those whom are positive for S.aureus, will be decolonized with Mupirocin2% made in Caspian company twice in day (each 12 hours) during 5 days and then will be checked three days after treatment. Third, those patients whom are positive for S.aureus but do not need any intervention. Inclusion criteria 16 years and more, All Patients have been admitted to Intensive Care Unit ward. Exclusion criteria: No complete treatment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013110915327N1
Registration date: 2014-01-31, 1392/11/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Farzaneh Jahani
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3645
Email address
jahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Arak University Of Medical Sciences
Expected recruitment start date
2013-11-26, 1392/09/05
Expected recruitment end date
2014-07-27, 1393/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Mupirocin effect on Nasal Staph aureus decolonization and prevention of Intensive Care Unit infection: A Clinical Trial
Public title
Study of the Mupirocin effect on Nasal Staph aureus decolonization and prevention of Intensive Care Unit infection: A Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients admitted to Intensive Care Unit ; Age 16 years and more. Exclusion criteria: incomplete treatment period
Age
From 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 170
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization has been done by Block Random Sampling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University Of Medical Sciences
Street address
Payambar Azam University Complex, Basij Sq, Sardasht, Arak
City
Arak
Postal code
Approval date
2013-10-28, 1392/08/06
Ethics committee reference number
6-153-92

Health conditions studied

1

Description of health condition studied
Nosocomial Infection with staphylococcus aureus
ICD-10 code
A49.0-
ICD-10 code description
Staphylococcal infection, unspecified site

Primary outcomes

1

Description
Nasal carrierity
Timepoint
48 hours after admission
Method of measurement
Positive Culture

2

Description
Staphylococcus aureus infection
Timepoint
During the time of hospitalization and 10 days after discharge
Method of measurement
Positive Culture

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: persons who have positive cultivation using mupirosin2% made in Caspian company twice in day (each 12 hours) during 5 days
Category
Treatment - Drugs

2

Description
Control group1: Persons who have negative cultivation and are followed up
Category
N/A

3

Description
Control group 2: Persons who have positive cultivation but don't get any treatment and are followed up
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Valie Asr Educational Hospital
Full name of responsible person
Dr. Zeynab Saeedinejad
Street address
Second floor, Infection ward, Valie Asr Educational Hospitall, Valie Asr Sq, Arak
City
Arak

2

Recruitment center
Name of recruitment center
AmirAl Momenin Educational Hospital
Full name of responsible person
Dr. Zeynab Saeedinejad
Street address
Second floor, Infection Ward, AmirAl Momenin Educational Hospital, Basij Sq, Sardasht, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University Of Medical Sciences
Full name of responsible person
Dr. Saeed Changizi Ashtiani
Street address
Second floor, Vice Chancellor for research, Basij Sq, Sardasht, Arak
City
Arak
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 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
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr.Zeynab Saeedinejad
Position
Resident of Infection Diseases
Other areas of specialty/work
Street address
Second floor, Infection Section, Valie Asr Educational Hospital, Valie Asr Sq, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
dr.saeedinejad@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Ehsan Alah Ghaznavi Rad
Position
PhD in Microbiology
Other areas of specialty/work
Street address
Third floor, Microbiology Group, PayambareAzam University Complex, Basij Sq, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86 3417 3635
Fax
Email
ghaznavieh@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
Farzaneh Jahani
Position
Bachelor of Science
Other areas of specialty/work
Street address
Second floor, Deputy of Research, Basij Sq, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
jahani@arakmu.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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