Comparison of response to treatment and outcome between triple therapy (colistin + meropenem + ampicillin-sulbactam) and dual therapy (colistin + ampicillin-sulbactam) in patients with carbapenem-resistant Acinetobacter infection admitted to ICU; A randomized controlled trial

Comparison of response to treatment and outcome between triple therapy (colistin + meropenem + ampicillin-sulbactam) and dual therapy (colistin + ampicillin-sulbactam) in patients with carbapenem-resistant Acinetobacter infection admitted to ICU

Clinical trial with control group, with parallel groups, randomized, phase 1 on 46 patients. The rand function of Excel software was used for randomization.

The study will be conducted in the ICU department of Bohlul Gonabad Hospital. Patients who are eligible to enter the study will be included in the study as available and are randomly divided into two groups, the first group will be prescribed three-drug treatment and the second group will be prescribed two-drug treatment. The primary outcome of clinical success will be after 14 days from the start of treatment. Only the evaluators of the research team will be blinded and patients will not be blinded.

The studied population in this study are patients hospitalized in ICU with carbapenem-resistant Acinetobacter infections. Inclusion criteria: Consent of the patient (in case of unconsciousness, his/her companion) ;Hospitalization in ICU; Age 18 years or above; Possible or definite infection with ventilator-associated pneumonia or hospital-acquired pneumonia or urosepsis or blood infection of any origin; Report of Acinetobacter in culture from the site of infection; Acinetobacter resistance to carbapenems.

Group A: Colistin 9 million units loading dose and then 4.5 million units every 12 hours + meropenem 2 grams every 8 hours + ampicillin sulbactam 3 grams every 6 hours Group B: Same as group A, without meropenem administration.

Clinical success; all cause mortality after 14 days, microbiological failure, duration of fever; Length of stay in ICU

The samples will be determined by random block method with blocks of 4 and using random numbers table of Random Allocation Software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The ratio of allocation of samples will be 1:1. Based on the obtained blocks and according to the sequence of allocation, the drugs will be given to the patients. The method is that we determine the number of blocks according to the sample size. Each block is numbered and is used for 4 patients. For example, if block number 2 is selected in the lottery and its treatment group is ABAB, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B.