Evaluation of the efficacy of colistin / levofloxacin in comparison with colistin / meropenem in the treatment of ventilator-associated pneumonia (VAP) induced by carbapenem-resistant Acinetobacter baumannii: a randomized, controlled clinical trial
1.Determining the number of treatments, clinical improvement and treatment failure (clinical response) in the experimental group after treatment
2. Determining the number of treatments, clinical improvement and treatment failure (clinical response) in the control group after treatment
3. Comparison 1 and 2
4. Determining the number of cases of microbial eradication and microbial failure (microbiological response) in the experimental group after treatment
Determining the number of other microbial cases and microbial failure (microbiological response) in the control group after treatment
6. Compare 4 and 5
7. Determining the index of clinical score of lung infection (clinical score of lung infection [CPIS]) in the experimental group before and after the intervention
Design
Two arm parallel group randomized controlled clinical trial. Online randomization program will be used for randomization.
Settings and conduct
This study will be a randomized and controlled clinical trial. Patients are selected from the intensive care unit (ICU) of Al-Zahra, Amin and Ayatollah Kashani hospitals in Isfahan. Adults with ventilator-associated pneumonia (VAP) are evaluated for inclusion in the study.
Participants/Inclusion and exclusion criteria
Age over 18 years
Under mechanical ventilation (intubation) for more than 48 hours
VAP diagnosis
Growth of carbapenem-resistant Acetobacter baumannii (Meropenem) in culturing lung secretions
Intervention groups
Experimental group: colistin (4.5 MU IV q12h) + levofloxacin (750 mg IV q24h)
Control group: colistin (4.5 MU IV q12h) + meropenem (1 g IV q8h)
Main outcome variables
Clinical response (cure, improvement, or failure)
CPIS score;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N17
Registration date:2021-05-12, 1400/02/22
Registration timing:prospective
Last update:2021-05-12, 1400/02/22
Update count:0
Registration date
2021-05-12, 1400/02/22
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-08-26, 1401/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of colistin / levofloxacin in comparison with colistin / meropenem in the treatment of ventilator-associated pneumonia (VAP) induced by carbapenem-resistant Acinetobacter baumannii: a randomized, controlled clinical trial
Public title
Comparison of colistin / levofloxacin combination with colistin / meropenem combination in the treatment of ventilator-dependent upper respiratory tract (VAP) induced by Acinetobacter: a randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Under mechanical ventilation (intubation) for more than 48 hours
VAP diagnosis
Growth of carbapenem (meropenem)-resistant Acinetobacter baumannii in the lung secretions culture
Exclusion criteria:
Pregnancy
Lactation
Sensitivity to meropenem, colistin, or levofloxacin
Acute Respiratory Distress Syndrome
Active pulmonary tuberculosis
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used for patients' allocation to the groups. For this, an online random number generator is used (available at: https://www.random.org/sequences) so that even and odd numbers will be considered for experimental and placebo groups, respectively, and each patient, after inclusion, will be assigned to the related group according to the determined sequence.
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 Isfahan University of Medical Sciences
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
خیابان هزار جریب
Approval date
2020-12-09, 1399/09/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.606
Health conditions studied
1
Description of health condition studied
Ventilator-induced pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Clinical Response (defined as cure or improvement or treatment failure)
Timepoint
End of intervention
Method of measurement
Clinical judgment by the observation of the patient
Secondary outcomes
1
Description
Clinical Pulmonary Infection Score (CPIS)
Timepoint
Before and after the intervention
Method of measurement
Questionnaire
2
Description
Mortality rate during the intervention
Timepoint
The end of intervention
Method of measurement
Counting
Intervention groups
1
Description
Experimental group: colistin (4.5 MU IV q12h) + levofloxacin (750 mg IV q24h), for 10 days
Category
Treatment - Drugs
2
Description
Control group: colistin (4.5 MU IV q12h) + meropenem (1 g IV q8h), for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital; Amin Hospital of Isfahan; Kashani Hospital
Full name of responsible person
Dr. Rasool Soltani
Street address
Isfahan, Sefeh St., Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar-Jerib Avenue, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
reasearch@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
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
En Confidentiality of patients data
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