Comparison of efficacy of Colistin IV, Colistin Nebulized with Colistin IV, Meropenem in the treatment of ventilator associated pneumonia caused by MDR gram negative microorganisms, a randomized clinical trial
Comparison of efficacy and safety of Colistin IV/Colistin nebulized and colistin IV/Meropenem in the treatment of pneumonia caused by gram negative MDR bacteria
Design
This is an open-label randomized clinical trial. Patients will be equally assigned to any of the groups according to permuted block randomization method.
Settings and conduct
Patients of intensive care units of Imam Khomeini Hospital Complex with the inclusion criteria, will be randomly assigned to either the groups.
Participants/Inclusion and exclusion criteria
Inclusion: Diagnosis of ventilator-associated pneumonia; clinical symptoms of pneumonia occurred after 24-48 hours of intubation, along with a positive endotracheal aspirate culture
Exclusion: Previous untreated pneumonia, age of less than 16 years, a sensitive antibiogram, a history of allergy to carbapenems and or colistin
Intervention groups
Group1:Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour + Meropenem 2g every 8 hour as iv infusion over 3 hours for at least 7 days
Group2: Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour + Nebulized colistin 2 MIU every 8 hour using jet nebulizer for at least 7 days
(Dose adjustments will be done according to patient's renal states)
Main outcome variables
Clinical improvement of pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190616043906N1
Registration date:2020-03-01, 1398/12/11
Registration timing:registered_while_recruiting
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
Sepideh Goudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
s-goudarzi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-12, 1398/10/22
Expected recruitment end date
2021-01-11, 1399/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Colistin IV, Colistin Nebulized with Colistin IV, Meropenem in the treatment of ventilator associated pneumonia caused by MDR gram negative microorganisms, a randomized clinical trial
Public title
Nebulized colistin in pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of pneumonia 48 hours after intubation (radiographical, laboratory and clinical findings along with a positive tracheal aspirate culture)
Exclusion criteria:
Signs of previous pneumonia at the time of intubation
No concomitant antibiotics indicated to treat pneumonia other than the study (but allowed for other infections)
Patients with a positive culture but no clinical and radiological findings for pneumonia
An antibiogram sensitive to any antibiotocs else than polymixins
Any history of allergy and seizure caused by Carbapenems/Colistin
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done according to the blocks randomization method. In accordance with the sample size, seven blocks will be chosen. Random sequences will be created by SAS software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods street
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.TUMS.VCR.REC.1398.800
Health conditions studied
1
Description of health condition studied
Ventilator-associated pneumonia
ICD-10 code
J15.0
ICD-10 code description
Pneumonia due to Klebsiella pneumoniae
Primary outcomes
1
Description
Clinical response of pneumonia to the treatment regimen
Timepoint
Days 2 and 7
Method of measurement
Evaluating vital signs, oxygenation, laboratory and hemodynamic parameters
2
Description
Incidence of acute kidney injury
Timepoint
Days 2 and 7
Method of measurement
According changes in serum creatinine levels and urine volume
Secondary outcomes
empty
Intervention groups
1
Description
Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour + Colistin nebulized 2 MIU every 8 hour using jet nebulizer for at least 7 days
Category
Treatment - Drugs
2
Description
Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour+ Meropenem 2g every 8 hour as iv infusion over 3 hours for at least 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2756
Email
Khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6658 1598
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6658 1598
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Goudarzi
Position
ُُStudent
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Fax
Email
s-goudarzi@student.tums.ac.ir
Web page address
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the article.
When the data will become available and for how long
One year after the end of the study, data will be published and will be available in databases.
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes.
Under which criteria data/document could be used
Other researchers are permitted to include the results in their systematic reviews and meta-analysis upon citing the original article.
From where data/document is obtainable
For this you may ask Hossein Khalili through following information: Address: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, depending on the type of requested data, the person responsible for scientific issues of the study will respond to the query within 2 weeks, after an agreement with the sponsor.