Comparison of the different doses of vancomycin on plasma concentration of the drug in patients hospitalized in ICU: a double blind randomized clinical trial
Objectives: To assess the effect of different doses of vancomycin on plasma concentration of the drug in patients hospitalized in ICU.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible patients who need to hospitalize in ICU wards and will refer to Sina Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 60 years; meningitis or endocarditis or sepsis or osteomyelitis with positive culture for staph or enterococci resistant to methicillin.
Exclusion criteria: Hypersensitivity to vancomycin; renal toxicity; using aminoglycoside drugs concurrently.
Intervention group 1: First injection of 1 g vancomycin as single dose and then 2 g per day for 2 weeks.
Intervention group 2: First injection of 1 gr vancomycin as single dose and then 15 mg/kg per day for 2 weeks.
Primary outcome: Measuring plasma concentration of vancomycin through High Performance Liquid Chromatography 2 months after treatment.
Randomization: / Random assignment of the patients to the intervention and control groups through drawing of lot.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710109014N194
Registration date:2017-10-12, 1396/07/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the different doses of vancomycin on plasma concentration of the drug in patients hospitalized in ICU: a double blind randomized clinical trial
Public title
Comparison of the different doses of vancomycin on plasma concentration of the drug in patients hospitalized in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 60 years; meningitis or endocarditis or sepsis or osteomyelitis with positive culture for staph or enterococci resistant to methicillin.
Exclusion criteria: Hypersensitivity to vancomycin; renal toxicity; using aminoglycoside drugs concurrently.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: / Random assignment of the patients to the intervention and control groups through drawing of lot.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.UMSHA.REC.1396.88
Health conditions studied
1
Description of health condition studied
Meningitis
ICD-10 code
G00
ICD-10 code description
Bacterial meningitis, not elsewhere classified
2
Description of health condition studied
Endocarditis
ICD-10 code
I33
ICD-10 code description
Acute and subacute endocarditis
3
Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified
4
Description of health condition studied
Osteomyelitis
ICD-10 code
M86
ICD-10 code description
Osteomyelitis
Primary outcomes
1
Description
Measuring plasma concentration of vancomycin
Timepoint
2 months after treatment
Method of measurement
Through High Performance Liquid Chromatography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: First injection of 1 g vancomycin as single dose and then 2 g per day for 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: First injection of 1 gr vancomycin as single dose and then 15 mg/kg per day for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammadali Salahshoor
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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, Hamadan 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
School of Pharmacy
Full name of responsible person
Mohammadali Salahshoor
Position
Student of Pharmacology
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
mohammadali.salahshoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy
Full name of responsible person
Dr Katayoon Derakhshandeh
Position
Pharmacist
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
k.derakhshandeh@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)