Clinical Trials List
2025-03-31 - 2028-06-30
Others
Recruiting13
ICD-10B64
Unspecified protozoal disease
ICD-10B89
Unspecified parasitic disease
ICD-10B99.9
Unspecified infectious disease
ICD-9136.9
Unspecified infectious and parasitic diseases
A Retrospective, Observational, Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Infusions of Polymyxin B and Colistin Methanesulfonate in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infection
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Trial Applicant
TTY Biopharm Company Limited
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Sponsor
TTY Biopharm Company Limited
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
- 邱勝康 Division of Infectious Disease
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
- 蔡明道 Division of Infectious Disease
- Jann-Tay Wang Division of Infectious Disease
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
- Kuo-Chin Kao Division of General Internal Medicine
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Co-Principal Investigator
- Chung-Hao Huang Division of Infectious Disease
- Po-Liang Lu Division of General Internal Medicine
- Wei-An Chang Division of Thoracic Medicine
- jong rung Tsai Division of Thoracic Medicine
- Chun-Yuan Lee Division of Infectious Disease
- Chau-Chyun Sheu Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- Shang-Yi Lin Division of Infectious Disease
- Tun-Chieh Chen Division of Infectious Disease
- 鄭至宏 Division of Thoracic Medicine
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Co-Principal Investigator
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Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Clinical response rate of two treatment groups at TOC
Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Microbiological response rate of two treatment groups at TOC
All-cause mortality of two treatment groups at Day 28
Infection-related mortality of two treatment groups at Day 28
Inclution Criteria
2. Patient diagnosed with bacterial pneumonia and/or bacteremia, or other physician judged serious infection (except urinary tract infection, UTI) caused by 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.
• ≥ 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)
• CXR or lung CT: presence of new or progressive infiltrates suggestive of bacterial pneumonia.
Diagnosis Criteria of BSI/Bacteremia: the BSI/sepsis category included bacteremia or sepsis caused by infections other than HABP/VABP, or UTI:
• Documented BSI caused by a carbapenem-resistant Gram-negative pathogen; or
• Systemic response to infection, meeting the clinical criteria of SIRS and an identified infection source (eg, severe skin infection, intra-abdominal infection) caused by a carbapenem-resistant Gram-negative pathogen.
3. Patient received intravenous polymyxin B or CMS treatment for ≥72 h.
4. 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
2. CR-GNB known to be resistant to polymyxin B or CMS.
3. 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.
4. Intravenous administration of polymyxin B or colistin more than 28 days.
5. Both the treatment efficacy and safety could not be evaluated.
The Estimated Number of Participants
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Taiwan
480 participants
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Global
480 participants
