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.
Study Type
OBSERVATIONAL
Enrollment
480
Clinical response rate of polymyxin B and CMS treatment groups at TOC
Time frame: TOC: End of Treatment + 7 days
Microbiological response rate of polymyxin B and CMS treatment groups at TOC
Time frame: TOC: End of Treatment + 7 days
All-cause mortality of of polymyxin B and CMS treatment groups at Day 28
Time frame: Day 28 from start of treatment
Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Time frame: End of Treatment + 7 days
Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Time frame: End of Treatment + 7 days
Infection-related mortality of two treatment groups at Day 28
Time frame: Day 28 from start of treatment
Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups
Time frame: Day 7, Day 14, Day 28, and EOT
Clinical response rate (Day 7, Day 14, Day 28 and EOT) of polymyxin B group by sites of infection and infectious pathogens
Time frame: Day 7, Day 14, Day 28, and EOT
Clinical response rate (Day 7, Day 14, Day 28, EOT, and TOC) of polymyxin B group by baseline renal function
Time frame: Day 7, Day 14, Day 28, EOT, and TOC
Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups
Time frame: Day 7, Day 14, and EOT
Microbiological response rate (Day 7, Day 14, and EOT) of polymyxin B group by sites of infection and infectious pathogens
Time frame: Day 7, Day 14, and EOT
Microbiological response rate (Day 7, Day 14, EOT, and TOC) of polymyxin B group by baseline renal function
Time frame: Day 7, Day 14, EOT, and TOC
All-cause mortality (Day 14) of two treatment groups
Time frame: Day 14 from start of treatment
All-cause mortality (Day 14, Day 28) of polymyxin B group by sites of infection, infectious pathogens, and baseline renal function
Time frame: Day 14, Day 28 from start of treatment
Infection-related mortality (Day 14) of two treatment groups
Time frame: Day 14 from start of treatment
Infection-related mortality (Day 14, Day 28) of polymyxin B group by sites of infection, infectious pathogens, and baseline renal function
Time frame: Day 14, Day 28 from start of treatment
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