Comparison of effect of administration of vancomycin by continuous infusion versus intermittent infusion on concentration of vancomycin in the CSF in postneurosurgical meningitis patients
Aim of study: Determine an appropriate therapeutic regimen for postneurosurgical meningitis patients in order to achieve desired vancomycin concentration in CSF.
Study design: random; without placebo; single center;
Method: Population of study: patients with postneurosurgical meningitis;
Inclusion criteria:
Patients who diagnosed postneurosurgical meningitis and received vancomycin;
Age>18 years old;
Exclusion criteria:
Chronic kidney disease (creatinine clearance<50 mL/min) before initiate threatment;
Occurring of acute kidney disease (according to the AKIN);
Administration of intrathecal vancomycin;
Through level<15mcg/mL;
Through level>30mcg/mL;
Sample volume: 20 patient
Intervention: infusion of high dose of vancomycin in two methods: intermittent infusion and continuous infusion;
Time of intervention: 21 days; from start of treatment till end of it;
Result: vancomycin concentration in CSF; vancomycin concentration in serum; treatment efficacy.
Method: 20 patients distribute in two equal groups randomly. In one group, at first, 10 patients will receive loading dose of 30 mg/kg then maintenance dose of 25 mg/kg twice daily by intermittent infusion. In another group, at first, 10 patients will receive loading dose of 30 mg/kg then maintenance dose of 50 mg/kg by continuous infusion. In addition, both groups will receive meropenem (2g IV TDS) and dexamethasone (10 mg IV QID) as conventional treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071114693N6
Registration date:2016-10-08, 1395/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-08, 1395/07/17
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of administration of vancomycin by continuous infusion versus intermittent infusion on concentration of vancomycin in the CSF in postneurosurgical meningitis patients
Public title
Vancomycin dosing in treatment of meningitis
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: patients who diagnosed postneurosurgical meningitis and received vancomycin; Age>18 years old)
(Exclusion criteria: chronic kidney disease (creatinine clearance<50 mL/min) before initiate threatment; occurring of acute kidney disease (according to the AKIN); administration of intrathecal vancomycin; through level<15mcg/mL; through level>30mcg/mL)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Shahid Beheshti University of Medical Sciences
Street address
tehran- velengak- shahid beheshti university of medical sciences
City
tehran
Postal code
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
SBMU2.REC.1394.128
Health conditions studied
1
Description of health condition studied
postneurosurgical meningitis
ICD-10 code
G00.1, G00
ICD-10 code description
Pneumococcal meningitis, Streptococcal meningitis
Primary outcomes
1
Description
CSF vancomycin concentration
Timepoint
day 3 and day 5 of treatment
Method of measurement
mcg/mL, Fluorescent PolarizationImmunoassay, by Cobas system
2
Description
serum concentration of vancomycin
Timepoint
day 3 and 5 of treatment
Method of measurement
mcg/mL, Fluorescent PolarizationImmunoassay, by Cobas system
Secondary outcomes
empty
Intervention groups
1
Description
vancomycin, 25 mg/kg Q12H, intermittent infusion, twice daily, for 21 days
Category
Treatment - Drugs
2
Description
vancomycin, 50mg/kg, continuous infusion, for 21 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr. Sahraee Zahra, Board Certified Pharmacotherapy Specialists
Street address
Loghman Hakim Hospital, Makhsoos St, South Karegar Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Nima Naderi
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Taheri Morteza
Position
Resident of Pharmacotherapy
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 9770
Fax
Email
morteza.taheri83@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sahraee Zahra
Position
Board Certified Pharmacotherapy Specialist
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 0118
Fax
Email
zahra.sahraee@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)