Protocol summary
-
Study aim
-
Evaluation the clinical effects of two regimens with different doses of ampicillin/sulbactam in patients with ventilator associated pneumonia caused by resistant Acinetobacter baumannii
-
Design
-
Randomized clinical trial with parallel groups on 60 patients. Block randomization method will be used trough online website.
-
Settings and conduct
-
This study is conducted in Loqman Hakim Hospital in Tehran. Patients are divided into two groups after evaluating the inclusion criteria. The first group receives meropenem at a dose of 1 g every 8 hours + colistin at dose of 4.5 million units every 12 hours + ampicillin sulbactam at a dose of 6 g every 6 hours, and the second group receives meropenem at a dose of 1 g every 8 hours + colistin at dose of 4.5 million units every 12 hours + ampicillin sulbactam injection at a dose of 9 grams every 6 hours.
-
Participants/Inclusion and exclusion criteria
-
In this study, patients over 18 years are included who their infection caused by a mechanical ventilation device and the resistant Acinetobacter baumannii. The patients sign an informed consent form before entering the study. Breastfeeding or pregnant patients were not included in the study.
-
Intervention groups
-
The first group (low dose): receiving Meropenem at a dose of 1 gram every 8 hours + Colistin injection 4.5 million units every 12 hours + Ampicillin/Sulbactam at a dose of 6 grams every 6 hours
The second group (high dose): receiving Meropenem at a dose of 1 gram every 8 hours + Colistin 4.5 million units every 12 hours + Ampicillin/Sulbactam at a dose of 9 grams every 6 hours
-
Main outcome variables
-
The primary outcome in this study includes the percentage of patients who improved without changing their antibiotic regimen during the study as well as the mortality rate of patients at the end of the study.
General information
-
Reason for update
-
The study has been completed and a series of inclusion and exclusion criteria that were required during the study were set.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180802040665N2
Registration date:
2024-02-28, 1402/12/09
Registration timing:
prospective
Last update:
2025-12-06, 1404/09/15
Update count:
1
-
Registration date
-
2024-02-28, 1402/12/09
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-03-05, 1402/12/15
-
Expected recruitment end date
-
2024-08-05, 1403/05/15
-
Actual recruitment start date
-
2024-03-05, 1402/12/15
-
Actual recruitment end date
-
2025-03-21, 1404/01/01
-
Trial completion date
-
2025-04-21, 1404/02/01
-
Scientific title
-
Clinical Evaluation of Two Regimens with Different Doses of Ampicillin/Sulbactam in Patients with Ventilator Associated Pneumonia Caused By Resistant Acinetobacter Baumannii
-
Public title
-
Clinical Evaluation of Ampicillin/Sulbactam in Patients with Ventilator Associated Pneumonia
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients aged more than 18 years old
VAP diagnosis according to the IDSA guidelines (new pulmonary infiltration with clinical symptoms including fever, purulent secretions, leukocytosis, and decreased blood oxygen levels occurring after 48 hours of mechanical ventilation).
Sign the informed consent form
Reporting of resistance Acinetobacter in the pulmonary secretion (concurrent resistance to aminoglycosides, fluoroquinolones, cephalosporins, penicillins and carbapenems).
Patients who received empiric antibiotic regimen consist of meropenem (at dose of 1000 mg IV q8h) and vancomycin (at dose of 15 mg/kg IV q12h) for the first 48 hours until the results of the culture are determined.
Exclusion criteria:
Breastfeeding and pregnant patients.
Patients who have an infection of another source other than the infection caused by the mechanical ventilation device.
Obese patients with body mass index more than 35.
Patients who have a history of allergy to medicines in the therapeutic regimen.
Patients with underlying lung diseases, immunocompromised patients, and those with recurrent lung infection.
Patients presenting with sepsis at the commencement of the study, according to the 2021 sepsis campaign guidelines.
Individuals with pre-existing pulmonary conditions, such as chronic obstructive pulmonary disease (COPD), lung cancer, or pulmonary thromboembolism (PTE).
Patients whose antibiotic treatment may be altered in terms of dosage and administration schedule.
Patients experiencing a hypersensitivity reaction during the course of the medication.
Patients who have ceased medication for a duration of less than 10 days.
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
2-3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
60
Actual sample size reached:
77
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Block randomization method was used in this study. 15 blocks including 4 patients generated with online website. In each block, two patients will be assigned to group A and two patients will be assigned to group B.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-08-01, 1402/05/10
-
Ethics committee reference number
-
IR.SBMU.PHARMACY.REC.1402.094
Health conditions studied
1
-
Description of health condition studied
-
Ventilator associated Pneumonia
-
ICD-10 code
-
J95.851
-
ICD-10 code description
-
Ventilator associated pneumonia
Primary outcomes
1
-
Description
-
The percentage of patients who recovered without changing their antibiotic regimen during the study.
-
Timepoint
-
10 days after the start of the study
-
Method of measurement
-
Relief of fever, reduction of purulent secretions and no need for vasopressor for at least 48 hours
2
-
Description
-
Mortality rate
-
Timepoint
-
10 days after the start of the study
-
Method of measurement
-
Evaluation of patients' medical records
Secondary outcomes
1
-
Description
-
The percentage of patients who manage to be weaned from mechanical ventilation or tolerate spontaneous breathing mode.
-
Timepoint
-
10 days after the start of the study
-
Method of measurement
-
Evaluation of patients' ventilators
2
-
Description
-
Length of stay in ICU
-
Timepoint
-
10 days after the start of the study
-
Method of measurement
-
Evaluation of patients' medical records
3
-
Description
-
Percentage of patients who develop the adverse drug reactions
-
Timepoint
-
Daily up to 10 days
-
Method of measurement
-
Examination of patients
Intervention groups
1
-
Description
-
Intervention group: receiving Meropenem injection at a dose of 1 gram every 8 hours + Colistin injection 4.5 million units every 12 hours + Ampicillin/Sulbactam injection at a dose of 9 grams every 6 hours
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: receiving Meropenem injection at a dose of 1 gram every 8 hours + Colistin injection 4.5 million units every 12 hours + Ampicillin/Sulbactam injection at a dose of 6 grams every 6 hours
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is 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
-
Title and more details about the data/document
-
All potential data can be shared after blinding
-
When the data will become available and for how long
-
Six mounts after results published
-
To whom data/document is available
-
Researchers working in academic institutions
-
Under which criteria data/document could be used
-
For research purposes and meta analysis
-
From where data/document is obtainable
-
Dr. Zahra Sahraei Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy, 3rd floor, Department of Clinical Pharmacy Zip Code: 1996835113 Telephone: +982188200209 Email: z.sahraei@sbmu.ac.ir
-
What processes are involved for a request to access data/document
-
Official letter to the researchers, then after 7 days, their request will be answered.
-
Comments
-