The efficacy and safety of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii
Evaluating the efficacy and safety of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii
Design
Two arm parallel group randomised trial with single blinded
Settings and conduct
Patients admitted to the intensive care unit of Imam Hossein Hospital in Tehran with ventilator-associated pneumonia are divided into two intervention groups and evaluate the efficacy and safety of them
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Participant with hospital admission days or endotracheal intubation days > 48 hours
Pneumonia diagnosis as clinical features, biologic and radiographic evidences
Sputum culture of Acinetobacter baumannii
Exclusion criteria:
Have received effective antibiotics for this episode of hospital acquired Pneumonia for more than 72 hours before study medication administration
Patients on dialysis
Immunodeficiency
Sever Acute respiratory distress syndrome (PaO2/Fio2 < 100)
Co-infection in another organs
Intervention groups
Intervention group:
intravenous ampicillin-sulbactam 6 g every 6 hours plus
nebulized colistin 2mIU every 8 hours
Control group:
intravenous colistin 9 mIU stat then 4.5 mIU every 12 hours plus
nebulized colistin 2mIU every 8 hours
Main outcome variables
Microbiological evaluation; clinical and radiological symptoms evaluation; serum level of PCT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120703010178N18
Registration date:2019-03-13, 1397/12/22
Registration timing:registered_while_recruiting
Last update:2019-03-13, 1397/12/22
Update count:0
Registration date
2019-03-13, 1397/12/22
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-09, 1397/12/18
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy and safety of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii
Public title
Comparison of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participant with endotracheal intubation days > 48 hours
Pneumonia diagnosis as clinical features (which include the new onset of fever (T > 38), purulent sputum, leukocytosis or leukopenia (WBC > 11000 cells/mm3 or < 4000 cells/mm3), biologic (microorganism concentration in sputum >〖10〗^5 CFU⁄ml) and radiographic evidences (new lung infiltrates)
Sputum culture of Acinetobacter baumannii
Exclusion criteria:
History of hypersensitivity reactions to beta-lactam antibiotics or colistin
Have received effective antibiotics for this episode of ventilator associated pneumonia for more than 72 hours before study medication administration
Patients on dialysis
Immunodeficiency (HIV with CD4 < 200 cells/mm3, ANC < 500/mm3، leukemia, lymphoma, chemotherapy within the last 3 weeks)
Sever Acute respiratory distress syndrome (PaO2/Fio2 < 100)
Endobronchial obstruction such as stenosis or mass in the endobronchial
Sever bronchospasm
Lung abscess
Empyema
Chest trauma
Co-infection in another organs
Comorbidities: cystic fibrosis، myasthenia or atelectasis
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning each regimen to patients is randomized and random blocked blocks with block size 4 (using a permuted block randomization table).
Blinding (investigator's opinion)
Single blinded
Blinding description
Based on randomization table, patients will be recruited. Nurse will prepare medications based on physician's order. Patient's who will receive medications, are not aware of allocation in study arms.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, Faculties of Pharmacy and Nursin
Street address
Faculty of pharmacy, Niayesh and Vali-e-Asr junction
City
tehran
Province
Tehran
Postal code
1991953381
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.007
Health conditions studied
1
Description of health condition studied
Ventilator-Associated Pneumonia due to Acinetobacter baumannii
ICD-10 code
J15.6
ICD-10 code description
Pneumonia due to other aerobic Gram-negative bacteria
Primary outcomes
1
Description
microbiological evaluation
Timepoint
Before intervention and 4, 7 , 10 days after intervention
Method of measurement
Negative sputum culture for Acinetobacter
Secondary outcomes
1
Description
clinical signs evaluation
Timepoint
4, 7 , 10 days after intervention
Method of measurement
Removing clinical and improving radiological manifestations - Successful weaning from ventilator between days 5 to 14 - Negative sputum culture for acinetocanter
2
Description
side effects evaluation
Timepoint
Daily and until antibiotics are given
Method of measurement
Laboratory measurements Cr
3
Description
Procalcitonin level evaluation
Timepoint
before intervention and 4, 7 , 10 days after intervention
Method of measurement
Laboratory scaling
Intervention groups
1
Description
Intervention group: intravenous ampicillin sulbactam 6 g every 6 hours plus nebulized colistin 2 mIU every 8 hours
Category
Treatment - Drugs
2
Description
Control group: intravenous colistin 9 mIU stat then 4.5 mIU every 12 hours plus nebulized colistin 2 mIU every 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive Care Unit, Imam Hussein medical center
Full name of responsible person
Mohammad Sistanizad
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2309
Email
sistanizadm@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd Floor, School of Medicine, Next to the Taleghani Hospital, Evin, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Fax
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mohammad Sistanizad
Position
Associated Professor / Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218800087
Email
sistanizadm@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Associated Professor, Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218800087
Email
sistanizadm@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Pourheidar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8896 5097
Email
e.pourheidar@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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available