Evaluating the Effectiveness of Nebulized Amikacin and Colistin in Preventing Ventilator-Associated Pneumonia in Intubated Patients Admitted to Intensive Care Units: A Clinical Trial

Evaluation of the efficacy of nebulized amikacin and colistin in preventing ventilator-associated pneumonia in intubated patients admitted to intensive care units

The clinical trial will involve 3 groups, including a control group, with parallel groups, single-blind, randomized, phase 2-3 on 126 patients. Randomization will be performed using the rand function in Excel.

The study will be conducted in a single-blind manner in the intensive care unit ,where patients and the statistical analyst are unaware of the patient categorization. The study will focus on patients without pulmonary infection who are under mechanical ventilation in the hospital's intensive care unit to prevent VAP. The medications will be administered to the patients via a jet nebulizer.

Patients will be selected from adults on invasive mechanical ventilation for at least 48 hours. Exclusion criteria include those on mechanical ventilation for 120+ hours, suspected or confirmed pneumonia, َAKI, tracheostomy tube, scheduled extubation within 24 hours, current or resistant aminoglycoside therapy, history of myasthenia gravis, non-VAP-related mortality risks, or aminoglycoside allergy. Patients who die from other causes, like pulmonary embolism or myocardial infarction, will also be excluded.

Colistin nebulizer group: Administered three times a day for three days with a dose of 2,000,000 units diluted in 2.5 mL of NS. Amikacin nebulizer group: Administered with a dose of 1,500 mg once a day for the same duration as the colistin group. Control group: 2 mL of deionized water with 1 mL of 0.9% sodium chloride, nebulized once a day for three days.

The primary outcome is the incidence of ventilator-associated pneumonia. Secondary outcomes include mortality incidence, intubation duration, and adverse events.

Patients will be randomly assigned in a 1:1:1 ratio to three groups using simple individual randomization. The allocation will be conducted using a random number assignment software based on multiples of 3. Allocation concealment will be ensured by a secure central online server and will not be disclosed to the patients.

The group allocation of patients in each category will only be known to the investigator and the drug prescriber. Study participants, outcome assessors, and data analysts will remain blinded to the patient groupings. The patient groupings will be recorded on a secure server. During the data analysis phase, each patient group will be assigned a code that only the investigator will know.

Due to the need for patient confidentiality

The final study report will be submitted to the Research Department of Tehran University of Medical Sciences. Additionally, the results of this study will be published as a scientific article in international journals. A blank consent form obtained from the patients will be attached as supplementary material to the report and the article.

End of the project: August 2024.

Public access

If there is a need to study the collected data or to conduct a similar research project, requests for data can be made to the project lead.

Send an email to the corresponding author, Dr. Mohammad Reza Salehi, at the address: salehi.mohamad3@gmail.com

If a request for data access is made, it will be discussed with all project leads and the ethics committee. If all parties agree, the information will be made available to the researchers.