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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment: Polymyxin B | |||
| Comparator: colistin methanesulfonate |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate of polymyxin B and CMS treatment groups at TOC | TOC: End of Treatment + 7 days | |
| Microbiological response rate of polymyxin B and CMS treatment groups at TOC | TOC: End of Treatment + 7 days | |
| All-cause mortality of of polymyxin B and CMS treatment groups at Day 28 | Day 28 from start of treatment | |
| Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC | End of Treatment + 7 days | |
| Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC | End of Treatment + 7 days | |
| Infection-related mortality of two treatment groups at Day 28 | Day 28 from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups | 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 | Day 7, Day 14, Day 28, and EOT |
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Inclusion Criteria:
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).
CR-GNB: Resistant to at least one of the carbapenem antibiotics or produce a carbapenemase (an enzyme that can make them resistant to carbapenem antibiotics).
Diagnosis Criteria of HABP/VABP:
• Met the clinical diagnosis criteria for HABP/VABP. HABP: Acute bacterial pneumonia in a subject hospitalized for more than 48 hours or developing within 7 days after discharge from a hospital. Subject could have experienced acute respiratory failure and required mechanical ventilation for HABP.
VABP: Acute bacterial pneumonia in a subject receiving mechanical ventilation via an endotracheal (or nasotracheal) tube for a minimum of 48 hours.
Diagnosis Criteria of BSI/Bacteremia: the BSI/sepsis category included bacteremia or sepsis caused by infections other than HABP/VABP, or UTI:
Patient received intravenous polymyxin B or CMS treatment for ≥72 h.
Administration of polymyxin B or CMS within 7 days from the infection onset day.
Infection onset day: The date of specimen collection for index pathogen.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angel Chen | Contact | 886 2 26525999 | 2227 | angel_chen@tty.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Recruiting | Taipei | Taiwan |
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| Clinical response rate (Day 7, Day 14, Day 28, EOT, and TOC) of polymyxin B group by baseline renal function | Day 7, Day 14, Day 28, EOT, and TOC |
| Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups | 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 | Day 7, Day 14, and EOT |
| Microbiological response rate (Day 7, Day 14, EOT, and TOC) of polymyxin B group by baseline renal function | Day 7, Day 14, EOT, and TOC |
| All-cause mortality (Day 14) of two treatment groups | 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 | Day 14, Day 28 from start of treatment |
| Infection-related mortality (Day 14) of two treatment groups | 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 | Day 14, Day 28 from start of treatment |
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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