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IRCT20150721023282N22 IRCT 2022-07-24 Esfahan University of Medical Sciences Comparison of colistin / rifampin combination with colistin / meropenem combination in the treatment of ventilator-dependent upper respiratory tract (VAP) induced by Acinetobacter: a randomized controlled clinical trial Evaluation of the effectiveness of colistin / rifampin compared to colistin / meropenem in the treatment of ventilator-associated pneumonia (VAP) due to carbapenem-resistant Acinetobacter baumannii: a randomized, controlled clinical trial 2022-08-23 anticipated 42 Complete https://irct.ir/trial/64716 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 2-3 Ventilator-induced pneumonia. Intervention 1: Intervention group: colistin (Product of Exir pharmaceutical company , 4.5 MU IV q12h) + rifampin (Product of Hakim Pharmaceutical Company , 300 mg PO q12h), for 10 days. Intervention 2: Control group: colistin (Product of Exir pharmaceutical company , 4.5 MU IV q12h) + meropenem (Product of Exir pharmaceutical company ,1 g IV q8h), for 10 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is En Confidentiality of patients data
public Rasool Soltani
Faculty of Pharmacy, Hezar-Jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Rasool Soltani
Faculty of Pharmacy, Hezar-Jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both Pregnancy Lactation Sensitivity to meropenem, colistin, or levofloxacin Acute Respiratory Distress Syndrome Active pulmonary tuberculosis J95.851 Ventilator associated pneumonia Treatment - Drugs Treatment - Drugs Intervention group: colistin (Product of Exir pharmaceutical company , 4.5 MU IV q12h) + rifampin (Product of Hakim Pharmaceutical Company , 300 mg PO q12h), for 10 days Control group: colistin (Product of Exir pharmaceutical company , 4.5 MU IV q12h) + meropenem (Product of Exir pharmaceutical company ,1 g IV q8h), for 10 days 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. Clinical Pulmonary Infection Score (CPIS). Timepoint: Before and after the intervention. Method of measurement: Questionnaire - Clinical Pulmonary Infection Scoring System. Mortality rate during the intervention. Timepoint: The end of intervention. Method of measurement: Counting. Esfahan University of Medical Sciences Approved 2022-07-02 Ethics committee of Isfahan University of Medical Sciences Hezar-Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)