Evaluating the effect of nebulizing colistine with nebulizing colistin-fosfomycin in comparison to nebulizing colistine in Ventillator-Associated Pneumonia with multidrug-resistant Acinetobacter Baumanii in Alzahra Intensive Care Units
Evaluating the effect of nebulizing colistine with nebulizing colistin-fosfomycin in comparison to nebulizing colistine in Ventillator-Associated Pneumonia with multidrug-resistant Acinetobacter Baumanii in Alzahra Intensive Care Units
Design
A randomized, double-blind, clinical trial
Settings and conduct
The study is being conducted at Alzahra Hospital in Isfahan. Ventilator pneumonia is diagnosed using the Clinical Pulmonary Infection Score (CPIS) score (0 to 10 points), which requires a culture of lung samples to assist in the clinical diagnosis of ventilator pneumonia (VAP). Tracheal Aspirate (TA) is a low-grade, invasive procedure for culture specimens, which is collected through a sterile suction catheter of the sputum sample. Within a maximum of 48 hours when the culture test results indicate Colistin-sensitive acinetobacter, the study is initiated and the patient is given intravenous meropenem, intravenous Colistin, and inhaled fosfomycin. Completion criteria: Fever, reduced lung discharge, or radiographic changes. The information becomes available to the analyzer after being unmarked.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patient hospitalization in ICU
Age between 20 and 85
Diagnosis of ventilator pneumonia for the patient
Diagnosis of colistin sensetive Acinetobacter baumannii
Patient satisfaction
Exclusion Criteria:
Diagnosis Another concomitant disease
Start treatment of acinetobacter
Intervention groups
The first group received inhaled Colistin and the second group received inhaled Colistin-fosfomycin treated with meropenem and intravenous choline. Each group included 39 patients with ventilator pneumonia whose response to culturing of their latent secretions was strongly resistant to Acinetobacter baumannii.
Main outcome variables
CPIS score, disease severity, response to treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N12
Registration date:2020-02-23, 1398/12/04
Registration timing:registered_while_recruiting
Last update:2020-02-23, 1398/12/04
Update count:0
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of nebulizing colistine with nebulizing colistin-fosfomycin in comparison to nebulizing colistine in Ventillator-Associated Pneumonia with multidrug-resistant Acinetobacter Baumanii in Alzahra Intensive Care Units
Public title
Evaluating the effect of nebulizing colistine with nebulizing colistin-fosfomycin in comparison to nebulizing colistine in Ventillator-Associated Pneumonia with multidrug-resistant Acinetobacter Baumanii in Alzahra Intensive Care Units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient hospitalization in ICU
Age between 20 and 85
Diagnosis of ventilator pneumonia for the patient
Diagnosis of colistin sensetive Acinetobacter baumannii
Patient satisfaction
Exclusion criteria:
Diagnosis Another concomitant disease
The patient died before the response
Start treatment of acinetobacter
Age
From 20 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will first be selected by convenience sampling from the ICU ward of Alzahra Hospital in Isfahan. They will then be randomly divided into two groups using binary replacement blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are admitted to the ICU and are unaware of the course of treatment of other treatment groups and are only aware of their treatment, and the analyzer does not know the patients and the treatment content.
Placebo
Not used
Assignment
Parallel
Other design features
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 Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-06-02, 1398/03/12
Ethics committee reference number
IR.MUI.MED.REC.1398.404
Health conditions studied
1
Description of health condition studied
Ventillator-Associated Pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Duration of treatment
Timepoint
Upon completion of treatment and response to treatment
Method of measurement
Counting the days of hospitalization and receiving treatment until the response arrives
2
Description
Illness severity
Timepoint
Before and after taking the drug
Method of measurement
Based on CPIS criteria
3
Description
Response to treatment
Timepoint
Before and after taking the drug
Method of measurement
Based on microbial eradication criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group is treated with inhaled Colistin, along with meropenem and intravenous Colistin. The study included 39 patients with ventilator pneumonia whose response to culturing of their secretions was strongly resistant to Acinetobacter baumannii. Intervention may be termination of fever, reduction of lung discharge or radiographic changes.
Category
Treatment - Drugs
2
Description
Intervention group:The second group is treated with inhaled Colistin-fosfomycin in combination with intravenous meropenem and Colistin. The study included 39 patients with ventilator pneumonia whose response to culturing of their secretions was strongly resistant to Acinetobacter baumannii. Intervention may be termination of fever, reduction of lung discharge or radiographic changes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Atusa Hakami Fafd
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khalili@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Vice-Chancellor for Research of School of Medicine,. Isfahan University of Medical Sciences,. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
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
Atusa Hakami Fafd
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
a.hakamifard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atusa Hakami Fafd
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
a.hakamifard@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atusa Hakami Fafd
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
a.hakamifard@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Two years after the results are shared.
When the data will become available and for how long
Two years after the results are shared.
To whom data/document is available
Doctors and Infectious Diseases
Under which criteria data/document could be used
Comparison of the new treatment with the present one
From where data/document is obtainable
Send an email to a.hakamifard@med.mui.ac.ir
What processes are involved for a request to access data/document