Evaluation of Aerosolized (AS) Colistin as Adjunctive Treatment Versus Intravenous Colistin Alone in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by Multidrug-resistant Gram-negative Bacteria
Evaluation of the efficacy and safety of aerosolized (AS) colistin in conjunction with IV colistin in patients with Ventilator-associated Pneumonia (VAP), caused by Multidrug Resistant (MDR) Gram Negative Bacteria (GNB)
Design
Two arm parallel group clinical trial with blinded outcome assessment was conducted on patients with VAP in Intensive Care Unit (ICU) ward. Twenty seven patients allocated into intervention or control group.
Settings and conduct
The study was conducted on patients with VAP admitted to ICU ward at Masih Daneshvari Hospital in Tehran. Patients in intervention group received IV Colistin based on (Glomerular filtration rate) along with aerosolized Colistin 2 million units three times a day. In the control group only IV Colistin was administered. For all patients Creatinine clearance, Procalcitonin (PCT), Sputum culture and Clinical Pulmonary Infection Score (CPIS) were measured at specified period of time. Investigator, outcome assessors, and data analyser were blind to the study groups untill the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient above 18 years, diagnosed with VAP، positive culture for MDR-GNB and sensitive to colistin
Exclusion criteria: Pregnant or lactated Patient, patient with septic shock
Intervention groups
Intervention group: Patients in this group received IV Colistin based on Glomerular filtration rate (GFR) with aerosolized Colistin, 2 million units three times a day.
Control group: Only received IV Colistin.
Main outcome variables
Evaluation of correlation between antibiotic initiation and the time of negative Sputum culture; Comparison of improvement in clinical signs of infection among intervention and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N9
Registration date:2018-08-15, 1397/05/24
Registration timing:retrospective
Last update:2018-08-15, 1397/05/24
Update count:0
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-04, 1395/01/16
Expected recruitment end date
2018-04-05, 1397/01/16
Actual recruitment start date
2016-04-04, 1395/01/16
Actual recruitment end date
2017-05-20, 1396/02/30
Trial completion date
empty
Scientific title
Evaluation of Aerosolized (AS) Colistin as Adjunctive Treatment Versus Intravenous Colistin Alone in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by Multidrug-resistant Gram-negative Bacteria
Public title
The Role of Aerosolized Colistin in the Treatment of Ventilator-associated Pneumonia, Caused by Multidrug-resistant Gram-negative Bacteria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Antibiogram of positive culture that is sensitive to Colistin and resistant to all other antibiotics
The new continuous pulmonary secretions based on lung radiography among patients who are received mechanical ventilation for at least 48 hours
Fever above 38ºC without any specific reason
White Blood Cell number more than 12000 cells or less than 4000 cells in each milliliter
Purulent tracheal secretions
Exclusion criteria:
Pregnancy
Breastfeeding
Septic shock
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Actual sample size reached:
27
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator, outcome assessors, and data analyser were blind to the study groups untill the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Pharmacy, Nursing, and midwifery; Shahid Beheshti University of Medica
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
141556153
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.SBMU.PHNM.1394.312
Health conditions studied
1
Description of health condition studied
Ventilator-associated Pneumonia (VAP)
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
The correlation between antibiotic therapy initiation and the time of negative procalcitonin (PCT) test
Timepoint
Days of 0, 3, 5, 7 after antibiotic initiation
Method of measurement
Immunochromatographic test (PCT-Q)
2
Description
The correlation between antibiotic therapy initiation and the time of negative sputum culture
Timepoint
Days of 0, 4, 7 after antibiotic initiation
Method of measurement
Sputum culture
Secondary outcomes
1
Description
Duration of ICU stay
Timepoint
Daily
Method of measurement
By the date of admission and discharge mentioned in Clinical records
2
Description
Time of fever discontinuation
Timepoint
Every other day
Method of measurement
Thermometer
3
Description
The correlation between antibiotic therapy initiation and the reduction of WBC
Timepoint
Every other day
Method of measurement
Hematologic test
4
Description
The correlation between antibiotic therapy initiation and improvement of PaO2/FiO2
Timepoint
Every other day
Method of measurement
By arterial and venous blood gasses (ABG and VBG)
5
Description
Chest X-Ray changes
Timepoint
Every other day
Method of measurement
By chest x-ray radiography
6
Description
Improvement of Clinical Pulmonary Infection Score (CPIS)
Timepoint
Every other day
Method of measurement
BY CPIS score
7
Description
All the adverse effects associated with the use of colistin including bronchospasm, neurotoxicity, and hypersensitivity reactions
Timepoint
Daily
Method of measurement
Clinical records
Intervention groups
1
Description
Intervention group: Received IV colistin (Colistimethate Sodium Injection, powder for solution parenteral 1000000 [IU] that belongs to Forest Laboratories Uk) based on Glomerular Filtration Rate (GFR) plus two million units of AS colistin , three times per day. Dose adjustments of IV Colistin were implemented based on table that belongs to Systematic review of the evidence for rational dosing of colistin. Prescribtion of IV colistin was countinued until the infection was completely resolved; AS colistin was prescribed only for a period of seven days (OMRON Mesh Nebulizer Model NE-U22). To prevent bronchospasm caused by nebulized colistin, patients were premedicated with salbutamol prior to administration of nebulized colistin.
Category
Treatment - Drugs
2
Description
Control group: Intravenous Colistin based on Glomerular Filtration Rate
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
National Research Institute of Tuberculosis and Lung Diseases, Dr. Masih Daneshvari Hospital
Full name of responsible person
Dr Farzaneh Dastan
Street address
Shahid Bahonar Ave., Darabad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
fzh.dastan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
141556153
Phone
+98 21 8820 0118
Email
pr_pharmacy@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Committee, School of Pharmacy, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faezeh Feizabadi
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 2230 8287
Fax
Email
faezehfe@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Farzaneh Dastan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8887 3704
Fax
Email
fzh.dastan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Farzaneh Dastan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8887 3704
Fax
Email
fzh.dastan@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available