]>
IRCT20100107003014N26 IRCT 2023-11-13 Mazandaran University of Medical Sciences Efficacy of levofloxacin and colistin inhalation form in treatment of pneumonia Comparison the efficacy of adding levofloxacin and colistin inhalation form to basic regimen of colistin and meropenem in treatment of ventilator associated pneumonia (VAP) caused by multidrug resistant pathogens: a double-blind randomized clinical trial 2023-10-23 anticipated 46 Complete https://irct.ir/trial/72850 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting patients with inclusion criteria, random allocation will be done by block method. Blocking process will be done with Random allocation software. With this software, the number of blocks and the size of each block will be determined. The samples are entered into the study based on the randomly generated numbers, Blinding description: The diagnosis of VAP will be made by special care specialists (project partners). Consumable vials for use in the nebulizer device will be purchased from a pharmaceutical company, and the appearance of the vials will be similar. The ward nurse is in charge of preparing the device and prescribed inhaler for patients to use. Covering the therapeutic intervention is done for the clinical pharmacy assistant and the person who examines the study results. 1-2 Ventilator associated pneumonia (VAP) caused by multidrug resistant pathogens. Intervention 1: Intervention group: Inhaled colistin at a dose of 2 million units every 8 hours with ultrasound nebulizer along with meropenem infusion 1 gram every 8 hours for 3 hours and colistin infusion at a dose of 9 million units loading and then 4.5 million units every 12 hours for 1 hour up to 7 days. Intervention 2: Intervention group: Inhaled levofloxacin vial with a dose of 250 mg every 12 hours with ultrasound nebulizer along with meropenem infusion 1 gram every 8 hours for 3 hours and colistin infusion at a dose of 9 million units loading and then 4.5 million units every 12 hours for 1 hour up to 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Shahram Ala
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran,
Sari Iran (Islamic Republic of) 4815733971 +98 11 3354 3083 sala@mazums.ac.ir Mazandaran University of Medical Sciences scientific Shahram Ala
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran
Sari Iran (Islamic Republic of) 4815733971 +98 11 3354 3083 sala@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age older than 18 years and less than 80 years Mechanical ventilation for more than 48 hours Pneumonia diagnosis based on the 2016 guidelines of the Infectious Diseases Society of America (IDSA) CPIS score above 6 Positive culture of sputum sample and growth of gram-negative bacteria resistant to treatment (MDR) (Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacteriaceae, etc.) 18 years 80 years Both Pregnancy or breastfeeding History of allergy to any of the drugs Colistin, Levofloxacin and Meropenem Acute respiratory distress syndrome Pulmonary tuberculosis disease under treatment Cystic fibrosis disease Major interaction of other drugs used by the patient with levofloxacin, colistin or meropenem Baseline creatinine clearance less than 15 mL/min History of receiving antibiotics effective against MDR pathogens during hospitalization Presence of pneumonia before intubation J95.851 Ventilator associated pneumonia Treatment - Drugs Treatment - Drugs Intervention group: Inhaled colistin at a dose of 2 million units every 8 hours with ultrasound nebulizer along with meropenem infusion 1 gram every 8 hours for 3 hours and colistin infusion at a dose of 9 million units loading and then 4.5 million units every 12 hours for 1 hour up to 7 days Intervention group: Inhaled levofloxacin vial with a dose of 250 mg every 12 hours with ultrasound nebulizer along with meropenem infusion 1 gram every 8 hours for 3 hours and colistin infusion at a dose of 9 million units loading and then 4.5 million units every 12 hours for 1 hour up to 7 days Average CPIS score reduction in two groups. Timepoint: days 1, 5, 7 (or stop intervention day). Method of measurement: CPIS scoring table. The incidence of acute kidney injury (AKI) in patients of two groups during treatment according to the KDIGO definition, defined as increase in serum creatinine of 0.3 mg/dl or more within 48 hours or an increase in serum creatinine of ≥ 1.5 times. Timepoint: Days 1, 3, 5 and 7 of intervention. Method of measurement: Blood sample sent to the laboratory. Registration of bronchospasm complication occurred during treatment in two groups of patients. Timepoint: During the intervention. Method of measurement: Airway resistance in the ventilator. Improvement rate in compliance and resistance of the respiratory tract in patients of two groups. Timepoint: Days 1, 3, 5 and 7 of intervention. Method of measurement: Ventilator data and calculation according to the formula. Mortality rate of patients in two groups until the duration of hospitalization in ICU. Timepoint: During the intervention up to the duration of ICU stay. Method of measurement: Patient database. The 28-day mortality rate of patients in two groups. Timepoint: 28 days after pneumonia caused by mechanical ventilation. Method of measurement: Patient database. Mazandaran University of Medical Sciences Approved 2023-09-23 Ethics department of Mazandaran University of Medical Sciences Moallem square, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)