Clinical Trials List
2025-03-31 - 2028-06-30
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 evaluating the efficacy and safety of intravenously administered polymyxin B and colistin methanesulfonate in treating patients with carbapenem-resistant, Gram-negative bacterial infections.
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Trial Applicant
TTY Biopharm Company Limited
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Sponsor
TTY Biopharm Limited
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Trial scale
Taiwan Multiple Center
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Update
2026/08/10
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
- Fu-Der Wang Division of Infectious Disease
- 莊涵琄 Division of Infectious Disease
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Co-Principal Investigator
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Co-Principal Investigator
- Jann-Tay Wang Division of Infectious Disease
- 蔡明道 Division of Infectious Disease
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Co-Principal Investigator
- 林德宇 Division of Infectious Disease
- 王永志 Division of Infectious Disease
- 江宗達 Division of Infectious Disease
- 吳瑞欣 Division of Infectious Disease
- 汪靖勛 Division of Infectious Disease
- 邱俊翔 Division of Infectious Disease
- 陳冠宇 Division of Infectious Disease
- 黃瑞昌 Division of Infectious Disease
- 楊雅頌 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
- Chun-Yuan Lee Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- Wei-An Chang Division of Thoracic Medicine
- Chau-Chyun Sheu Division of Thoracic Medicine
- Tun-Chieh Chen Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- jong rung Tsai Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- 鄭至宏 Division of Thoracic Medicine
- Po-Liang Lu Division of General Internal Medicine
- 林俊佑 Division of Infectious Disease
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0 Recruiting
Co-Principal Investigator
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Co-Principal Investigator
- Kuo-Chin Kao Division of General Internal Medicine
- 莊立邦 Division of General Internal Medicine
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0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
2. Clinical response rate of the two treatment groups at TOC.
3. Microbiological response rate of the polymyxin B group assessed by infection site and infectious pathogen at TOC.
4. Microbiological response rate of the two treatment groups at TOC.
5. All-cause mortality rate of the two treatment groups at day 28.
6. Infection-related mortality rate of the 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 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.
•≥ 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
2CR-GNB known to be resistant to polymyxin B or CMS.
3Patient 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.
4Intravenous administration of polymyxin B or colistin more than 28 days.
5Both 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
