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IRCT20221102056386N2 IRCT 2023-04-17 Bandare-abbas University of Medical Sciences Comparison of two antibiotic regimens in patients with positive VAP caused by Acinetobacter Comparison of two antibiotic regimens in patients with positive Ventilator-associated pneumonia caused by Acinetobacter: an open-label clinical trial 2023-04-20 anticipated 102 Complete https://irct.ir/trial/69142 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: It will be explained to all participants before the start of the study that they will be randomly divided into two intervention groups (A) and (B). The random block allocation method is used to randomly divide the samples. In this trial, we will have two groups of 4 blocks (2 participants in drug group A and 2 in drug group B). The randomization tool is also random sequence generation software (random allocation software), which in addition to simple randomization, this random sequence generation software are capable of generating random sequences by the block method. Blocked randomization is for the purpose of making sure that precisely equal number of participants enter the intervention groups at consecutive but equal time intervals. 4 Acinetobacter infection. Intervention 1: Intervention group 1: Patients in this group receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion within one hour. In addition, they receive 6 grams of ampicillin sulbactam every 6 hours as a three-hour intravenous infusion, and the treatment process continues for 2 weeks. 51 patients will enter this group. Intervention 2: Intervention group 2: Patients in this group receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion within one hour. In addition, they receive 2 grams of TDS meropenem (every 8 hours) in the form of intravenous infusion over three hours, and the treatment process lasts for 2 weeks. 51 patients will enter this group. Yes - There is a plan to make this available What will be shared: the data will be collected by the colleagues participating in the project When: 6 month To whom: corresponding Author: Dr. Elham Berahimi, Dr. Saeed Shoja Conditions: Only for data collection and analysis Where to obtain: corresponding Author: Dr. Elham Berahimi, Dr. Saeed Shoja How to obtain: Written request and request of the project manager and main collaborators (Dr. Elham Berahimi, Dr. Saeed Shoja, Narjes Seddighi) Comments:
public saeed shoja
Vice Chancellor Deputy of research and technology, Campus of University of Medical Sciences, Nabout Town, in front of Kargaran Sports Club, at the beginning of Imam Hossein Boulevard, Bandar Abbas, Iran
bandar abbas Iran (Islamic Republic of) 79151 +98 76 3333 7192 shojasaeed@gmail.com Bandare-abbas University of Medical Sciences scientific Elham Berahimi
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
bandar abbas Iran (Islamic Republic of) 7919693116 +98 76 3333 7192 dr.berahimi@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Ventilator-Associated Pneumonia (VAP) confirmed by a doctor age 18 or older Hospitalization in the intensive care unit (ICU) obtaining informed consent from the patient or the patient's companion history of sensitivity to antibiotics in the laboratory 18 years no limit Both Organ transplant or bone marrow transplant Being treated for human immunodeficiency virus (HIV) Receiving another antibiotic from another hospital within less than 72 hours Pregnancy Having an incurable disease Blood malignancy without a treatment plan Resistance to therapeutic antibiotics Having another infection along with Ventilator-associated pneumonia (VAP) J15.8 Pneumonia due to other specified bacteria Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in this group receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion within one hour. In addition, they receive 6 grams of ampicillin sulbactam every 6 hours as a three-hour intravenous infusion, and the treatment process continues for 2 weeks. 51 patients will enter this group. Intervention group 2: Patients in this group receive 9 million units of colistin as a loading dose and then 4.5 million units of colistin every 12 hours as an intravenous infusion within one hour. In addition, they receive 2 grams of TDS meropenem (every 8 hours) in the form of intravenous infusion over three hours, and the treatment process lasts for 2 weeks. 51 patients will enter this group. Determining the effectiveness of the intervention. Timepoint: During the study period. Method of measurement: Examination of clinical symptoms during the intervention period. Comparison of hospitalization in ICU and hospital. Timepoint: Duration of the study. Method of measurement: check list. The effect of treatment on the duration of the patient's recovery during the intervention period. Timepoint: Duration of the study. Method of measurement: Clinical symptoms and laboratory tests. Mortality. Timepoint: end of the study. Method of measurement: check list. Kidney function. Timepoint: duration of the study. Method of measurement: Measurement of creatinine and blood urea nitrogen levels. Bandare-abbas University of Medical Sciences Approved 2023-03-11 Ethics committee of Hormozgan University of Medical Sciences Research and Technology Vice-Chancellor Building, Hormozgan University of Medical Sciences Campus, Imam Hossein Blvd. Bandarabbas Hormozgan Iran (Islamic Republic of)