This is a retrospective, observational, post-marketing study to evaluate the clinical response, microbiological response, mortality, and safety of intravenous polymyxin B and colistin methanesulfonate in patients with carbapenem-resistant gram-negative bacterial infection. Subgroup analysis by sites of infection, infectious pathogens, and baseline renal function will also be performed.
Patient ≥ 18 years of age.
Patient diagnosed with bacterial pneumonia and/or bacteremia, or other physician judged serious infection (except urinary tract infection, UTI) caused by Carbapenem-Resistant Gram-Negative Bacteria (CR-GNB).
≥ 1 of the following clinical features: new onset or worsening of pulmonary symptoms or signs, hypoxemia, need for acute changes in the ventilator support system to enhance oxygenation, new onset of or increase in suctioned respiratory secretions.
≥ 1 of the following signs: documented fever, hypothermia, WBC ≥ 10,000 cells/mm3, WBC ≤ 4500 cells/mm3, >15% immature neutrophils(bands)
Patient with bacteremia caused by urinary tract infection.
CR-GNB known to be resistant to polymyxin B or CMS.
Patient has infectious disease (s) caused by the following gram-negative bacteria which are known to have no response to polymyxin B and/or colistin treatment: Proteus spp., Providencia spp., Morganella spp., Serratia marcescens, Burkholderia spp., and Neisseria spp.
Intravenous administration of polymyxin B or colistin more than 28 days.
1. Intent-To-Treat (ITT) population 2. Total enrolled population
Cohort
Retrospective
Not listed
Clinical response rate of polymyxin B and CMS treatment groups at TOC
Microbiological response rate of polymyxin B and CMS treatment groups at TOC
All-cause mortality of of polymyxin B and CMS treatment groups at Day 28
Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups
Clinical response rate (Day 7, Day 14, Day 28 and EOT) of polymyxin B group by sites of infection and infectious pathogens
Clinical response rate (Day 7, Day 14, Day 28, EOT, and TOC) of polymyxin B group by baseline renal function
Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups
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