A comparison of therapeutic effects of teicoplanin versus vancomycin in patients admitted to the Intensive Care Unit after cardiac surgery because of MRSA infectious endocarditis in Masih Daneshvari hospital between years 2012-2016
This study intends to investigate the therapeutic effects of two drugs Vancomycin and Teicoplanin in clinical trial in patients hospitalized in intensive care after surgery for endocarditis infections caused by strains of methicillin-resistant Staphylococcus aureus. This study was done on 46 operated patient by surgery complications in infective endocarditis caused by strains of methicillin-resistant Staphylococcus aureus organisms. Patients with Prohibition of use for each of these two drugs were excluded from the study. This study was conducted as a double blind study which neither the patients, the experimenter were not aware of type of intervention. Randomized block design was used to random allocation of patients to two groups. Teicoplanin was used by intravenous and intramuscular injection and single dose daily. Initial Vancomycin dose was 1500 mg every 12 hours until serum concentration monitoring indicates the need for higher dosing. After two months Culture and isolation was compared in tow groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022220592N4
Registration date:2016-06-21, 1395/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-08-30, 1391/06/09
Expected recruitment end date
2016-08-30, 1395/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of therapeutic effects of teicoplanin versus vancomycin in patients admitted to the Intensive Care Unit after cardiac surgery because of MRSA infectious endocarditis in Masih Daneshvari hospital between years 2012-2016
Public title
A comparison of therapeutic effects of teicoplanin versus vancomycin in patients admitted to the Intensive Care Unit after cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: Prohibition of use for each of the two drugs
Inclusion Criteria:
Surgery complications in invective endocarditis caused by organisms
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Yemen Street, Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
SBMU.REC.1393.69
Health conditions studied
1
Description of health condition studied
Endocarditis
ICD-10 code
I33.9
ICD-10 code description
Acute endocarditis, unspecified
Primary outcomes
1
Description
Culture and isolation
Timepoint
at the start of the study and after 2 months
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intenvention : Teicoplanin, Teicoplanin was used by intravenous and intramuscular injection and single dose daily.
Category
Treatment - Drugs
2
Description
Control: Vancomycin, Initial Vancomycin dose was 1500 mg every 12 hours until serum concentration monitoring indicates the need for higher dosing.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Street Shaheed Bahonar Avenue Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Jamati
Street address
Shahid Beheshti University of Medical Sciences, Tabnak Street, Shahid Chamran Highway, 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
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad reza Hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad reza hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza Hashemiann
Position
Anethesiologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)