Comparison of the Efficacy of Intranasal Mupirocin Ointment with Povidone Iodine Solution on the Colonization of Staphylococcus aureus among Carrier Patients and Medical Staff
Comparison of the efficacy of intranasal mupirocin ointment with povidone iodine solution on the colonization of Staphylococcus aureus among carrier patients and medical staff
Design
Randomized, open-label clinical trial, with two parallel arms (allocation ratio 1:1).
Settings and conduct
This study will performe on patients undergoing hemodialysis and medical staff (carriers of Staphylococcus aureus in the nasal cavity) in Labbafinejad Hospital (Tehran) in 2022. Eligible patients are allocated to two groups using a random number table. Initially, all patients underwent baseline culture of the nasal cavity for Staphylococcus aureus. Group A recieves mupirocin ointment (topically in the nasal cavity twice a day) for five days. Group B recieves Povidone Iodine solution (topically in the nasal cavity twice daily) for five days. Then, nasal swab specimens are taken from all individuals and examined for colonization of Staphylococcus aureus. Finally, a change in the colonization of Staphylococcus aureus is reported in participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Patients undergoing hemodialysis in the dialysis ward of the hospital; or staff working in the hemodialysis, intensive care, operating room and infectious wards of the hospital, and positive culture of nasal specimens for Staphylococcus aureus. Exclusion criteria are: Immunocompromised patients, antibiotic consumption in the last 1 month, history of Hypersensitivity to intranasal mupirocin ointment or povidone iodine solution, and corticosteroids consumption.
Intervention groups
Group A receives mupirocin ointment (topically in the nasal cavity twice daily) for five days. Group B receives povidone iodine solution (topically in the nasal cavity twice daily) for five days.
Main outcome variables
Colonization of Staphylococcus aureus in the nasal cavity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033487N2
Registration date:2022-05-13, 1401/02/23
Registration timing:prospective
Last update:2022-05-13, 1401/02/23
Update count:0
Registration date
2022-05-13, 1401/02/23
Registrant information
Name
sara abilghasemi
Name of organization / entity
Shahid Beheshti university of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 911 354 8867
Email address
saraabolghasemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Intranasal Mupirocin Ointment with Povidone Iodine Solution on the Colonization of Staphylococcus aureus among Carrier Patients and Medical Staff
Public title
Comparison of the efficacy of intranasal mupirocin ointment with povidone iodine solution on the colonization of Staphylococcus aureus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis in the dialysis ward of the hospital; or staff working in the hemodialysis, intensive care, operating room and infectious wards of the hospital
Positive culture of nasal specimens for Staphylococcus aureus
Exclusion criteria:
Immunocompromised patients
Antibiotic consumption in the last 1 month
History of Hypersensitivity to intranasal mupirocin ointment or povidone iodine solution
Corticosteroids consumption
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).
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 committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-04-12, 1401/01/23
Ethics committee reference number
IR.SBMU.MSP.REC.1401.025
Health conditions studied
1
Description of health condition studied
Staphylococcus aureus carriers in the nasal cavity
ICD-10 code
B95.6
ICD-10 code description
Staphylococcus aureus as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Colonization of Staphylococcus aureus in the nasal cavity
Timepoint
Sixth day after the start of the intervention
Method of measurement
Laboratory report (culture in trypticase soy broth)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A receives mupirocin ointment (topically in the nasal cavity twice daily) for five days.
Category
Treatment - Drugs
2
Description
Intervention group: Group B receives povidone iodine solution (topically in the nasal cavity twice daily) for five days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Dr. Sara Abolghasemi
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
saraabolghasemi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sara Abolghasemi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
saraabolghasemi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sara Abolghasemi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
saraabolghasemi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sara Abolghasemi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
saraabolghasemi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available