Objective: comparison of efficacy of Vancomycin and Teicoplanin in treatment of catheter related infection. Study population: 43 Hemodialysis patients with fever. Inclusion criteria:patients with clinical suspicious of catheter infection after roll out of other causes of fever. Exclusion criteria:patients who had purulent discharge from catheter site at the beginning of study. Intervention: 22 patients received Teicoplanin 800mg intra venues as loading dose and 400mg at 2th,3th,5th,12th,19th days and 21 patients received Vancomycin 1gr intra venues as loading dose and 500mg each 5 days for 3 weeks. Criteria for Treatment response was absence of fever after 72 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903234144N2
Registration date:2010-06-13, 1389/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-13, 1389/03/23
Registrant information
Name
Maliheh Yarmohamadi
Name of organization / entity
Semnan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 0225
Email address
mds@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan university of medical sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-03-19, 1388/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effects of Teicoplanin versus Vancomycin in treatment of catheter infection in hemodialysis patients
Public title
Comparison between effects of Teicoplanin versus Vancomycin in treatment of catheter infection in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with clinical suspicious of catheter infection after roll out of other causes of fever. Exclusion criteria: patients who had purulent discharge from catheter site at the beginning of study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
43
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
Semnan university of medical sciences
Street address
5th kilometer of Damghan-Semnan road
City
Semnan
Postal code
Approval date
2009-05-18, 1388/02/28
Ethics committee reference number
1643/آ
Health conditions studied
1
Description of health condition studied
hemodialysis patients who had catheter infection
ICD-10 code
A00-B99
ICD-10 code description
Other infectious diseases
Primary outcomes
1
Description
absence of fever after 72 hours
Timepoint
24 hours
Method of measurement
thermometer
Secondary outcomes
1
Description
drug adverse effect
Timepoint
24 hours
Method of measurement
patient's complain and physical exam
Intervention groups
1
Description
Teicoplanin: 800mg intra venues as loading dose and 400mg at 2th,3th,5th,12th,19th days
Category
Treatment - Drugs
2
Description
Vancomycin: 1gr intra venues as loading dose and 500mg each 5 days for 3 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh hospital
Full name of responsible person
Maliheh Yarmohamadi
Street address
Fatemiyeh hospital, 17 shahrivar Blv
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Dr Mohamad Faranoush
Street address
central office of Semnan university of medical sciences, Basij blv
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan university of medical sciences
Full name of responsible person
Dr Maliheh Yarmohamadi
Position
Internal resident
Other areas of specialty/work
Street address
central office of Semnan university of medical sciences, Basij Blv
City
Semnan
Postal code
Phone
+98 23 1444 3912
Fax
Email
mds@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Dr Mohamadreza Tamadon
Position
Nephrologist
Other areas of specialty/work
Street address
Fatemiyeh hospital, 17 Shahrivar Blv
City
Semnan
Postal code
Phone
+98 23 1332 8017
Fax
Email
mrt_tamadon@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Dr Maliheh Yarmohamadi
Position
Internal resident
Other areas of specialty/work
Street address
central office of Semnan university of medical sciences, Basij Blv
City
Semnan
Postal code
Phone
+98 23 1444 3912
Fax
Email
mds@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)