Comparing nebulized colistin with nebulized Amikacin- Fosfomycin as an adjunctive treatment of ventilator associated pneumonia due to multi drug resistant acinetobacter
Comparing nebulized colistin with nebulized Amikacin- Fosfomycin as an adjunctive treatment of ventilator associated pneumonia due to multi drug resistant acinetobacter
Design
A randomized, double-blind, parallel clinical trial
Settings and conduct
The study is being conducted in the ICU ward of Alzahra Hospital in Isfahan. Fosfomycin solution with 4% concentration (2 ml of this solution, 80 mg proportion) is introduced into the nebulizer jet chamber for patient use. This is accomplished by filtration using 100 nm filters at the appropriate pH (about 7) and with the appropriate tonicity of body fluids that do not cause irritation when inhaled. The Clinical Pulmonary Infection Score (CPIS) criterion is used to diagnose ventilator pneumonia. The criterion consists of 5 sections, each with a score of 0 to 2, and patients score between 0 and 10. The mortality rate, if any, and the duration of treatment and the patient's exit from the VAP, if any, are then recorded. The results are then analyzed by the statistician after being anonymized.
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 cholesterol-sensitive Acinetobacter baumannii
Patient satisfaction
Exclusion Criteria:
Diagnosis Another concomitant disease
Start treatment of acinetobacter
Intervention groups
The first group is inhaled Amikacin + phosphomycin and the second group is inhaled colistin, which is treated with intravenous meropenem and clistine. Each group included 30 patients with a total of 60 patients with ventilator pneumonia whose response to culturing of their highly secreted Acinetobacter baumannii was selected from patients in the intensive care units of Al-Zahra Hospital.
Main outcome variables
Mortality rates, Duration of response to treatment , CPIS index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N13
Registration date:2020-03-02, 1398/12/12
Registration timing:registered_while_recruiting
Last update:2020-03-02, 1398/12/12
Update count:0
Registration date
2020-03-02, 1398/12/12
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
Comparing nebulized colistin with nebulized Amikacin- Fosfomycin as an adjunctive treatment of ventilator associated pneumonia due to multi drug resistant acinetobacter
Public title
Comparing nebulized colistin with nebulized Amikacin- Fosfomycin as an adjunctive treatment of ventilator associated pneumonia due to multi drug resistant acinetobacter
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 cholesterol-sensitive Acinetobacter baumannii
Patient satisfaction
Exclusion criteria:
Diagnosis Another concomitant disease
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are first conveniently and easily selected from the list of patients with ventilator pneumonia admitted to the ICU center of Alzahra Hospital in Isfahan and then divided into two groups of 30 each using double blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients admitted to the ICU are not aware of the therapeutic content and the data analyzer has no information about the name and other characteristics of the patients.
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
2019-04-17, 1398/01/28
Ethics committee reference number
IR.MUI.MED.REC.1398.139
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia due to multi drug resistant acinetobacter
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Mortality rates
Timepoint
After completing the study
Method of measurement
Counting the number of patients
2
Description
Duration of response to treatment
Timepoint
After completing the study
Method of measurement
Counting the number of days admitted and the number of patients saved
3
Description
CPIS index
Timepoint
Before and after treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The inhaled Amikacin + phosphomycin treatment group (treated with intravenous meropenem and clistine) included 30 patients with ventilator-associated pneumonia, whose response to cultures of severely resistant acinetobacter baumannii was noted, among patients admitted to the intensive care unit of Alzahra Hospital. Phosphomycin solution with 4% concentration (2 ml of this solution, 80 mg proportion) is introduced into the nebulizer jet chamber for patient use. This is accomplished by filtration using 100 nm filters at the appropriate pH (about 7) and with the appropriate tonicity of body fluids that do not cause irritation when inhaled. The Clinical Pulmonary Infection Score (CPIS) criterion is used to diagnose ventilator pneumonia. The criterion consists of 5 sections, each with a score of 0 to 2, and patients score between 0 and 10.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Inhaled clistine treatment group (treated with meropenem and intravenous clistine), including 30 patients with ventilator pneumonia, whose response to cultures of highly resistant acinetobacter baumannii was noted, was selected from patients in the intensive care units of Al-Zahra Hospital. Ventilator pneumonia diagnosis is used by the Clinical Pulmonary Infection Score (CPIS). The criterion consists of 5 sections each with a score of 0 to 2, and patients score between 0 and 10.
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, Sufeh Street.
City
Isfahan
Province
Isfehan
Postal code
81747-73461
Phone
+98 31 3668 0048
Email
a.hakamifard@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
The information is shared two years after the results are published.
When the data will become available and for how long
The information is shared two years after the results are published.
To whom data/document is available
Doctors and Infectious Diseases
Under which criteria data/document could be used
Comparison of medication or other treatment with present conditions
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