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Comparison of two antibiotic regimens in patients with positive Ventilator-associated pneumonia caused by Acinetobacter: an open-label clinical trial

Protocol summary

Study aim
The purpose of this study is to compare two antibiotic regimens in patients with positive Ventilator-associated pneumonia caused by Acinetobacter.
Design
This study is a clinical trial with parallel groups, without blinding, in which people are randomly divided into two groups of 51 people by Randomized Allocation Software.
Settings and conduct
This study will be conducted in Bandar Abbas Shahid Mohammadi Hospital affiliated with Hormozgan University of Medical Sciences. After explaining the study to the patient's companions and obtaining informed consent, the patients are placed in one of the two intervention groups and the treatment begins.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age, Acinetobacter infection confirmed by a physician, hospitalization in the intensive care unit, have a history of sensitivity to antibiotics in the laboratory, and obtain informed consent from the patient's companion. Non-entry criteria: All patients with a history of receiving an organ or bone marrow transplant, being treated for HIV, receiving another antibiotic from another hospital in less than 72 hours, pregnancy, having an incurable disease, blood malignancy without Having a treatment plan, Resistance to antibiotic treatment, Having another infection along with Ventilator-Associated Pneumonia.
Intervention groups
All patients receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion over one hour. Group 1: In addition, they receive 6 grams of ampicillin sulbactam every 6 hours as a three-hour intravenous infusion. Group 2: In addition, they receive 2 grams of meropenem (every 8 hours) in the form of intravenous infusion over three hours. treatment process continues for 2 weeks.
Main outcome variables
Determining the effectiveness of the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221102056386N2
Registration date: 2023-04-17, 1402/01/28
Registration timing: prospective

Last update: 2023-04-17, 1402/01/28
Update count: 0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Narjes Seddighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 185 1678
Email address
narjes.seddighi80@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-20, 1402/01/31
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two antibiotic regimens in patients with positive Ventilator-associated pneumonia caused by Acinetobacter: an open-label clinical trial
Public title
Comparison of two antibiotic regimens in patients with positive VAP caused by Acinetobacter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ventilator-Associated Pneumonia (VAP) confirmed by a doctor age 18 or older Hospitalization in the intensive care unit (ICU) obtaining informed consent from the patient or the patient's companion history of sensitivity to antibiotics in the laboratory
Exclusion criteria:
Organ transplant or bone marrow transplant Being treated for human immunodeficiency virus (HIV) Receiving another antibiotic from another hospital within less than 72 hours Pregnancy Having an incurable disease Blood malignancy without a treatment plan Resistance to therapeutic antibiotics Having another infection along with Ventilator-associated pneumonia (VAP)
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
It will be explained to all participants before the start of the study that they will be randomly divided into two intervention groups (A) and (B). The random block allocation method is used to randomly divide the samples. In this trial, we will have two groups of 4 blocks (2 participants in drug group A and 2 in drug group B). The randomization tool is also random sequence generation software (random allocation software), which in addition to simple randomization, this random sequence generation software are capable of generating random sequences by the block method. Blocked randomization is for the purpose of making sure that precisely equal number of participants enter the intervention groups at consecutive but equal time intervals.
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 Hormozgan University of Medical Sciences
Street address
Research and Technology Vice-Chancellor Building, Hormozgan University of Medical Sciences Campus, Imam Hossein Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7919693116
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.HUMS.REC.1401.411

Health conditions studied

1

Description of health condition studied
Acinetobacter infection
ICD-10 code
J15.8
ICD-10 code description
Pneumonia due to other specified bacteria

Primary outcomes

1

Description
Determining the effectiveness of the intervention
Timepoint
During the study period
Method of measurement
Examination of clinical symptoms during the intervention period

Secondary outcomes

1

Description
Comparison of hospitalization in ICU and hospital
Timepoint
Duration of the study
Method of measurement
check list

2

Description
The effect of treatment on the duration of the patient's recovery during the intervention period
Timepoint
Duration of the study
Method of measurement
Clinical symptoms and laboratory tests

3

Description
mortality
Timepoint
end of the study
Method of measurement
check list

4

Description
kidney function
Timepoint
duration of the study
Method of measurement
Measurement of creatinine and blood urea nitrogen levels

Intervention groups

1

Description
Intervention group 1: Patients in this group receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion within one hour. In addition, they receive 6 grams of ampicillin sulbactam every 6 hours as a three-hour intravenous infusion, and the treatment process continues for 2 weeks. 51 patients will enter this group.
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients in this group receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion within one hour. In addition, they receive 2 grams of TDS meropenem (every 8 hours) in the form of intravenous infusion over three hours, and the treatment process lasts for 2 weeks. 51 patients will enter this group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The Great Prophet Research and Educational Complex Research Center
Full name of responsible person
Elham Barahimi
Street address
The Great Prophet Research and Educational Complex Research Center, Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 917 159 2783
Email
dr.berahimi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
vali alipoor
Street address
Vice Chancellor Deputy of research and technology, Campus of University of Medical Sciences, Nabout Town, in front of Kargaran Sports Club, at the beginning of Imam Hossein Boulevard, Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
79151
Phone
+98 76 3333 7192
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
saeed shoja
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
bacteriology
Street address
Vice Chancellor Deputy of research and technology, Campus of University of Medical Sciences, Nabout Town, in front of Kargaran Sports Club, at the beginning of Imam Hossein Boulevard, Bandar Abbas, Iran
City
bandar abbas
Province
Hormozgan
Postal code
79151
Phone
+98 76 3333 7192
Email
shojasaeed@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elham Berahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
City
bandar abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3333 7192
Email
dr.berahimi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Narjes Seddighi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Southern Mission, Faculty of Paramedicine, Student Research Committee
City
bandar abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6367
Email
narjes.seddighi80@gmail.com

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 data will be collected by the colleagues participating in the project
When the data will become available and for how long
6 month
To whom data/document is available
corresponding Author: Dr. Elham Berahimi, Dr. Saeed Shoja
Under which criteria data/document could be used
Only for data collection and analysis
From where data/document is obtainable
corresponding Author: Dr. Elham Berahimi, Dr. Saeed Shoja
What processes are involved for a request to access data/document
Written request and request of the project manager and main collaborators (Dr. Elham Berahimi, Dr. Saeed Shoja, Narjes Seddighi)
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