the main goal of this study is comparison of high dose regimen of vancomycin with conventional regimen in acute bacterial meningitis and its specific goal is evaluating saftey and efficacy of high dose regimen of vancomycin.
Inclusion criteria:
Filling consent form
Patients with diagnosis of acute bacterial meningitis who are candidated for receiving vancomycin
Age≥18 yrs
Not receive vancomycin in last 2weeks
Exclusion criteria:
Clinical states which could change phahrmacokinetic of vancomycin (eg. burn, cystic fibrosis, edema)
Pregnancy
Patients with CKD who need dialysis
Contraindication for vancomycin
this study is a randomized controlled clinical trial which 40 patients with diagnosis of acute bacterial meningitis who have indication for recieving vancomycin included in it. they will be devided in two 20patients group, that first group will receive vancomycin with conventional dose (1000mg q12hr) and second group will receive it in high dose (1000mg q8hrs) in 1hour infusion. all patients will be evaluated during the study for clinical response on basis of laboratory parameters (CBC & LP findings), physiologic and clinical neurologic examination.at the begining of study and every other day 10cc blood sample will be drawn from all of the patients for evaluating the level of creatinine, KIM-1 and Cystatin-C.after infusion of third dose of vancomycin and in 10th day of therapy before morning dose,blood sample for measurement of serum trough level of vancomycin will be drawn. serum level of acute kidney injury biomarkers and vancomycin will be measured with ELISA kits and immunoassay methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107233449N7
Registration date:2011-08-08, 1390/05/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-08-08, 1390/05/17
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science (pharmacy faculty)
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of conventional vancomycin regimen (15mg/kg q12h) vs. high dose regimen (15mg/kg q8h) in acute bacterial meningitis patients
Public title
application of high dose regimen of vancomycin in acute bacterial meningitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Filling consent form; Patients with diagnosis of acute bacterial meningitis who are candidated for receiving vancomycin; Age≥18 yrs; Not receive vancomycin in last 2weeks
Exclusion criteria: Clinical states which could change phahrmacokinetic of vancomycin (eg. burn, cystic fibrosis, edema); Pregnancy; Patients with CKD who need dialysis ; Contraindication for vancomycin
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd.,Tehran University of Medical sciences, Central organization, 6th Floor