Protocol summary

Summary
the main goal of this study is evaluation of chemoprotective effect of NAC on vancomycin induced nephrotoxicity in acute bacterial meningitis patients and its specific goal is evaluating saftey and efficacy of NAC on vancomycin induced nephrotoxicity. Inclusion criteria: Filling consent form Patients with diagnosis of acute bacterial meningitis who are candidated for receiving vancomycin Age≥16 yrs Not receive vancomycin in last 2weeks Exclusion criteria: Clinical states which could change phahrmacokinetic of vancomycin (eg. burn, cystic fibrosis) Pregnancy Patients with CKD who need dialysis Contraindication for vancomycin, treatment with other nephrotoxic agents. this study is a randomized controlled clinical trial which 60 patients with diagnosis of acute bacterial meningitis who have indication for recieving vancomycin included in it. They will be devided in two 30patients group, that first group will receive vancomycin with NAC(1200mg BD) and second group will receive vancomyc in 1hour infusion. all patients will be evaluated during the study for clinical response on basis of laboratory parameters (CBC & LP findings), physiologic examination at the begining of study and 5 and 10 days of treatment,10cc blood sample will be drawn from all of the patients for evaluating the level of 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 creatinine will be checked every other days. serum level of acute kidney injury biomarker and vancomycin will be measured with standard methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013091814693N1
Registration date: 2013-10-03, 1392/07/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-10-03, 1392/07/11
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 Science (pharmacy faculty)
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2015-03-11, 1393/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of chemoprotective effect of NAC on vancomycin induced nephrotoxicity in acute bacterial meningitis patients
Public title
Chemoprotective effect of NAC on vancomycin induced nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Filling consent form; Patients with diagnosis of acute bacterial meningitis who are candidated for receiving vancomycin; Age≥16 yrs; Not receive vancomycin in last 2weeks Exclusion criteria: Clinical states which could change phahrmacokinetic of vancomycin (eg. burn, cystic fibrosis); Pregnancy; Patients with CKD who need dialysis ; Contraindication for vancomycin, treatment with other nephrotoxic agents.
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Vali-e Asr Ave.,Niayesh junction ,Shahid Beheshti University of Medical sciences
City
Tehran
Postal code
Approval date
2013-09-01, 1392/06/10
Ethics committee reference number
92-251

Health conditions studied

1

Description of health condition studied
acute bactrial meningitis
ICD-10 code
G00.9
ICD-10 code description
Bacterial meningitis, unspecified

Primary outcomes

1

Description
serum level of Cystatin-C
Timepoint
Baseline,5 and 10 days after treatment
Method of measurement
Turbidimetry

2

Description
serum level of vancomycin
Timepoint
Baseline,5 and 10 days after treatment
Method of measurement
immunoassay technique,mcg/ml

Secondary outcomes

1

Description
serum level of creatinine
Timepoint
every other days from begining of study
Method of measurement
jaffe method،mg/dl

Intervention groups

1

Description
that study group will receive NAC(1200mg BD) from begining of study until 10 days.
Category
Prevention

2

Description
Control group:standard regimen for treatment of meningitis
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman hakim Hospital
Full name of responsible person
Dr. Shervin Shokouhi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Pharmacy Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr zahra Sahraei
Street address
Vali-e Asr Ave.,Niayesh junction ,Shahid Beheshti University of Medical sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Pharmacy 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
Faculty of pharmacy
Full name of responsible person
Dr Morteza Taheri
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Vali-e Asr Ave.,Niayesh junction ,Shahid Beheshti University of Medical sciences
City
Tehran
Postal code
Phone
+218 8873704
Fax
Email
morteza.taheri83@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of pharmacy,Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Zahra sahraei, Azadeh Eshraghi
Position
Assistant professor,Resident of clinical pharmacy
Other areas of specialty/work
Street address
Vali-e Asr Ave.,Niayesh junction
City
Tehran
Postal code
Phone
+98 21 8820 0209
Fax
Email
z.sahraei@sbmu.ac.ir,aepharm@gmail.com
Web page address

Person responsible for updating data

Contact

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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