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IRCT20120703010178N18 IRCT 2019-03-13 Shahid Beheshti University of Medical Sciences Comparison of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii The efficacy and safety of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii 2019-03-09 anticipated 28 Complete https://irct.ir/trial/31904 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning each regimen to patients is randomized and random blocked blocks with block size 4 (using a permuted block randomization table), Blinding description: Based on randomization table, patients will be recruited. Nurse will prepare medications based on physician's order. Patient's who will receive medications, are not aware of allocation in study arms. 3 Ventilator-Associated Pneumonia due to Acinetobacter baumannii. Intervention 1: Intervention group: intravenous ampicillin sulbactam 6 g every 6 hours plus nebulized colistin 2 mIU every 8 hours. Intervention 2: Control group: intravenous colistin 9 mIU stat then 4.5 mIU every 12 hours plus nebulized colistin 2 mIU every 8 hours. 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 Patient privacy
public Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Participant with endotracheal intubation days > 48 hours Pneumonia diagnosis as clinical features (which include the new onset of fever (T > 38), purulent sputum, leukocytosis or leukopenia (WBC > 11000 cells/mm3 or < 4000 cells/mm3), biologic (microorganism concentration in sputum >〖10〗^5 CFU⁄ml) and radiographic evidences (new lung infiltrates) Sputum culture of Acinetobacter baumannii 18 years no limit Both History of hypersensitivity reactions to beta-lactam antibiotics or colistin Have received effective antibiotics for this episode of ventilator associated pneumonia for more than 72 hours before study medication administration Patients on dialysis Immunodeficiency (HIV with CD4 < 200 cells/mm3, ANC < 500/mm3، leukemia, lymphoma, chemotherapy within the last 3 weeks) Sever Acute respiratory distress syndrome (PaO2/Fio2 < 100) Endobronchial obstruction such as stenosis or mass in the endobronchial Sever bronchospasm Lung abscess Empyema Chest trauma Co-infection in another organs Comorbidities: cystic fibrosis، myasthenia or atelectasis Pregnancy and lactation J15.6 Pneumonia due to other aerobic Gram-negative bacteria Treatment - Drugs Treatment - Drugs Intervention group: intravenous ampicillin sulbactam 6 g every 6 hours plus nebulized colistin 2 mIU every 8 hours Control group: intravenous colistin 9 mIU stat then 4.5 mIU every 12 hours plus nebulized colistin 2 mIU every 8 hours Microbiological evaluation. Timepoint: Before intervention and 4, 7 , 10 days after intervention. Method of measurement: Negative sputum culture for Acinetobacter. Clinical signs evaluation. Timepoint: 4, 7 , 10 days after intervention. Method of measurement: Removing clinical and improving radiological manifestations - Successful weaning from ventilator between days 5 to 14 - Negative sputum culture for acinetocanter. Side effects evaluation. Timepoint: Daily and until antibiotics are given. Method of measurement: Laboratory measurements Cr. Procalcitonin level evaluation. Timepoint: before intervention and 4, 7 , 10 days after intervention. Method of measurement: Laboratory scaling. Shahid Beheshti University of Medical Sciences Approved 2018-04-30 Ethics committee of Shahid Beheshti University of Medical Sciences, Faculties of Pharmacy and Nursin Faculty of pharmacy, Niayesh and Vali-e-Asr junction tehran Tehran Iran (Islamic Republic of)