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IRCT20180802040665N2 IRCT 2024-02-28 Shahid Beheshti University of Medical Sciences Clinical Evaluation of Ampicillin/Sulbactam in Patients with Ventilator Associated Pneumonia Clinical Evaluation of Two Regimens with Different Doses of Ampicillin/Sulbactam in Patients with Ventilator Associated Pneumonia Caused By Resistant Acinetobacter Baumannii 2024-03-05 anticipated 60 Complete https://irct.ir/trial/75397 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 2-3 Ventilator associated Pneumonia. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after results published To whom: Researchers working in academic institutions Conditions: For research purposes and meta analysis Where to obtain: 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 How to obtain: Official letter to the researchers, then after 7 days, their request will be answered. Comments:
public Zahra Sahraei
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
Tehran Iran (Islamic Republic of) 1991953381 0098218200118 zahra.sahraei@yahoo.com Shahid Beheshti University of Medical Sciences scientific Elmira
Shool of Pharmacy, Shahid Beheshti University of Medical Sciences, Valiasr St, Tehran
Tehran Iran (Islamic Republic of) 1991953381 0098218200118 elmira_niknami@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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. J95.851 Ventilator associated pneumonia Treatment - Drugs Treatment - Drugs 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 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 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. Mortality rate. Timepoint: 10 days after the start of the study. Method of measurement: Evaluation of patients' medical records. 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. Length of stay in ICU. Timepoint: 10 days after the start of the study. Method of measurement: Evaluation of patients' medical records. Percentage of patients who develop the adverse drug reactions. Timepoint: Daily up to 10 days. Method of measurement: Examination of patients. Shahid Beheshti University of Medical Sciences Approved 2023-08-01 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)