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Comparison the effects of Meropenem, intravenous Colistin plus nebolized Colistin and Meropenem, intravenous Colistin plus nebolized Granulocyte Colony Stimulating Factor(G-CSF ) on treating patients with Ventilator Associated Pneumonia (VAP) due to multidrug_resistance Acinetobacter

Protocol summary

Study aim
Effect of nebolized G-CSF in treatment of VAP due to MDR Acinetobacter
Design
Two arm parallel group randomised trial with blinded postoperative care and outcom asssessmen.In this study 60 paitients VAP due to MDR Acinetobacter were selected base on inclusion and exclusion criteria for participation ,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 ventilation more than 48 hours, Multidrug rsistance Acinetobacter in tracheal culture, Satisfaction with the first class family Exclusion critera: Allergy to colistin, other infections
Intervention groups
Intervention group1: In group, patients that received Meropnem 2 gr every 8 hours, interavenous Colistin 4.5 milion iternational units(IU) every 12 hours and nebulized Colistin 4.5 (IU) every 12 hours daily for a period of 14 days then CPIS was determined at days 1,3,5,7,14 Intervention group2: In group, patients that received Meropnem 2 gr every 8 hours, interavenous Colistin 4.5 (IU) every 12 hours and nebulized G-CSF with the dose of 150 microgram every 48 hours for 14 days then CPIS was determined at days 1,3,5,7,14
Main outcome variables
CPIS score, achievement in treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150824023743N2
Registration date: 2019-07-31, 1398/05/09
Registration timing: retrospective

Last update: 2019-07-31, 1398/05/09
Update count: 0
Registration date
2019-07-31, 1398/05/09
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 Granulocyte Colony Stimulating Factor(G-CSF ) on treating patients with Ventilator Associated Pneumonia (VAP) due to multidrug_resistance Acinetobacter
Public title
Effect of nebolized G-CSF in treatment of Ventilator Associated Pneumonia (VAP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Mechanical ventilation more than 48 hours Multidrug resistance Acinetobacter in tracheal culture 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
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
2018-10-04, 1397/07/12
Ethics committee reference number
IR.MUI.MED.REC.1397.052

Health conditions studied

1

Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
B99-B99
ICD-10 code description
other infectious diseases

Primary outcomes

1

Description
Achieve in treatment
Timepoint
1,3,5,7 and 14 days after intervention
Method of measurement
Calculate the Clinical Pulmonary Infection Score table

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group patients that received Meropenem (Dana company) 2g every 8 hour , injectable Colistin ( Exir company) 4.5 million IU every 12 hour, plus nebulized G-CSF(Sinagen company) with the dose of 150 microgram every 48h for 14 days.
Category
Treatment - Drugs

2

Description
Control group: In this group patients that received Meropenem (Dana copmany) 2 gr every 8 hours, injectable Colistin (Exir company ) pluse nebulized Colistin 4.5 million units 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
Fatemeh Mohajeri
Street address
Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
mohajerifatemeh4@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohajeri
Street address
Isfahan Univresity of Medical Scinces, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mohajerifatemeh4@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Fatemeh Mohajeri
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
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohajerifatemeh4@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohajeri
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
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohajerifatemeh4@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohajeri
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
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mohajerifatemeh4@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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