In this clinical trial, 84 patients(male or female )with stroke and 20 years or older admitted to the neurology intensive care unit of Valiasr hospital will be enrolled based on inclusion and exclusion criteria. The demographic data including age, sex, underlying disease and the admission form will be recorded for each patient. The severity of illness will be assessed by using APACHE score. Written informed consent from the patient's Legal guardian will be obtained. The patients will be divided randomly into two equal groups. Patients in the combination piperacillin - tazobactam dose 4.5 g (piperacillin 4 g and tazobactam 0.5 g) coincides with intubation and then 12 hours later, will receive the control group received normal saline solution likewise. Then the process would be similar between the two groups. Finally the incidence of early ventilator associated pneumonia in patients in both groups as the primary outcome and duration of admission, early ventilator associated pneumonia and rate of mortality as a secondary outcome of this study will be discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407029855N6
Registration date:2014-07-21, 1393/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-21, 1393/04/30
Registrant information
Name
Aiasghar Farazi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 6526
Email address
dr.farazi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic antibiotic for Early Ventilator associated Pneumonia in stroke Patients
Public title
Prophylactic antibiotic in ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 20 years; Glasgow scale of less than 9, less than 12 hours of mechanical ventilation passed; at least 48 hours under of mechanical ventilation.
Exclusion criteria: patients who admitted 48 hours before intubation in hospital; patients who received more than two doses of antibiotics before intubation; Patients who have need antibiotics for any reason; patients who are candidates for organ donation; patients with immunodeficiency; patients who are allergic to piperacillin-tazobactam.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Arak University of Medical Sciences
Street address
School of Medicine, Sardasht,Arak
City
Arak
Postal code
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
92-157-8
Health conditions studied
1
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
Early ventilator associated pneumonia
Timepoint
Days 1,2,3,4
Method of measurement
Chest X ray, clinical signs, microbiological study
Secondary outcomes
1
Description
Late ventilator associated pneumonia
Timepoint
Days 5 , 7, 10 , 14
Method of measurement
Chest X ray, clinical sign and Microbiology study
2
Description
Mortality report
Timepoint
Daily to two weeks
Method of measurement
Reviewing date of death
3
Description
Length of stay in ICU
Timepoint
Daily to two weeks
Method of measurement
Reviewing date of discharge
Intervention groups
1
Description
Patients in the case group receive intravenous piperacillin - tazobactam 4.5 g (piperacillin 4 g and tazobactam 0.5 g) simultaneously with intubation and then 12 hours after intubation and simultaneously receive subsequent treatment that was similar in both groups.
Category
Prevention
2
Description
Patients in the control group receive intravenous normal saline simultaneously with intubation and then 12 hours after intubation and simultaneously receive subsequent treatment that was similar in both groups.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital in arak
Full name of responsible person
Dr.Aliasghar Farazi
Street address
Department of infectious diseases, Valiasr hospital, Arak Arak Markazi Iran, Islamic Republic Of
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpoo
Street address
School of Medicine, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. aliasghar Farazi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of infectious diseases, Valiasr hospital, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
farazialiasghar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Aliasghar Farazi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Infectious Diseases , Valiasr Hospital , Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
farazialiasghar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Aliasghar Farazi
Position
farazialiasghar@yahoo.com
Other areas of specialty/work
Street address
epartment of infectious diseases, Valiasr hospital, Arak Arak Markazi Iran, Islamic Republic Of Markazi Iran, Islamic Republic Of
City
Postal code
Phone
+98 86 3224 1411
Fax
Email
farazialiasghar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)