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Comparison the effects of Meropenem,intravenous Colistin plus nebolized Colistin and Meropenem,intravenous Colistin plus nebolized Tubramycin on treating patients with ventilator associated pneumonia (VAP) due to multidrug_resistance Acintobacter

Protocol summary

Study aim
Effect of nebolized Tubramycin in treatment of Ventilator Associated Pneumonia( VAP) due to Acintobacter multidrug resistance(MDR)
Design
Two arm parallel group randomised trial with blinded postoperative care and outcom assessmen.In this study 60 patients VAP due to Acintobacter MDR were selected based on inclusion and exclusion criteria for participation in this study ,then they were randomly assigned to two groups of 30 people
Settings and conduct
Alzahra hospital of Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age over 18 years, Mechanical intubation more than 48 hours,Acintobacter MDR in tracheal culture and satisfaction with the first class family Exclude criteria : Age under 18 years , Allergy to Colistin,other diseases
Intervention groups
Intervention group 1 : In this group, patients recieved Meropenem 2g every 8 hours,injectable colistin 4/5 million IU every 12 hours plus nebolized Colistin 4/5 million IU every 12 hours for the period of 14 days.then CPIS was determined on days 1 , 3 , 5 , 7 , 14. Intervention group 2 :In this group, patients recieved Meropenem 2g every 8 hours, injectable colistin r/5 million IU every 12 hours plus nebolized Tubramycin 300mg every 12 hours for the period of 14 days.then CPIS was determined on days 1 , 3 , 5 , 7 , 14
Main outcome variables
CPIS score, achivement in treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150824023743N3
Registration date: 2019-12-31, 1398/10/10
Registration timing: retrospective

Last update: 2019-12-31, 1398/10/10
Update count: 0
Registration date
2019-12-31, 1398/10/10
Registrant information
Name
Farzin Khorvash
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 313792900698
Email address
khorvash@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2018-04-21, 1397/02/01
Trial completion date
2018-04-21, 1397/02/01
Scientific title
Comparison the effects of Meropenem,intravenous Colistin plus nebolized Colistin and Meropenem,intravenous Colistin plus nebolized Tubramycin on treating patients with ventilator associated pneumonia (VAP) due to multidrug_resistance Acintobacter
Public title
Effect of nebolized Tubramycin in treatment of ventilator associated pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Mechanical ventilator more than 48 hours Multidrug_resistance Acintobacter in tracheal cultures Satisfaction with the first class family
Exclusion criteria:
Allergy to colistin Other infections
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization.since two groups of patients are needed for this study,six different blocks of 4 were considered and random number table was used to randomly place the numbers on the table and to move btween two numbers.select up and finally determined the order of the path blocks based on the order of these numbers.in this study,the order of the blocks was 3,5,6....finally 15 blocks of 4 were identified and the order of TCTC and then TCCT and...by doing this process,the patients were divided into two equal groups of intervention and control groups randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using block randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of Medical sciences
Street address
Isfahan University of Medical Sciences , Hezar Jerib Avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.MUI.REC.1396.3.768

Health conditions studied

1

Description of health condition studied
Ventilator associated pneumonis
ICD-10 code
B99-B99
ICD-10 code description
Other infectious disease

Primary outcomes

1

Description
Clinical pulmunary infection score
Timepoint
1 , 3 , 5 , 7 and 14 after intervention
Method of measurement
Calculate the clinical pulmunary infection score table

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group recieved Meropenem(Dana company) 2g every 8 hour , injectable Colistin(Exir company) 4/5 million IU every 12 hours , plus nebolized Tubramycin 300 mg every 12 hours for 14 days.
Category
Treatment - Drugs

2

Description
Control group: This group recieved Meropenem (Dana company) 2g every 8 hour , injectable Colistin (Exir company) 4/5 million IU every 12 hours , plus nebolized Colistin 4/5 million IU every 12 hours for 14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital of Isfahan
Full name of responsible person
Shoeleh yaghoubi
Street address
Alzahra hospital , Soffeh Avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 5555 3668
Email
Sholeyaqubi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Rasoul Roknizade
Street address
Isfahan University of medical science , Hezar Jerib Avenue , Isfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 0048 3668
Email
Sholeyaqubi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shoeleh Yaghoubi
Position
Assistant , infectious diseases and tropical medicine research center
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Isfahan University of Medical Science , Hezar Jerib Avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 0048 3668
Email
Sholeyaqubi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shoeleh Yaghoubi
Position
Assistant , Infectious diseases and tropical medicine research center
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Isfahan University of Medical Science , Hezar Jerib , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 0048 3668
Email
Sholeyaqubi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shoeleh yaghoubi
Position
Assistant , infectious diseases and tropical medicine research center
Latest degree
Medical doctor
Other areas of specialty/work
Infectious disease
Street address
Isfahan University of Medical Sciences , Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 0048 3668
Email
Sholeyaqubi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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