2025-03-31 - 2028-06-30
其他
召募中13
ICD-10B64
原蟲病
ICD-10B89
寄生蟲病
ICD-10B99.9
傳染病
ICD-9136.9
傳染病及寄生虫病
一項回溯性、觀察性，評估靜脈輸注之多粘菌素B（Polymyxin B）及粘杆菌素（Colistin Methanesulfonate）對於治療碳青黴烯類抗生素（Carbapenem）抗藥性、革蘭氏陰性菌株感染病人療效與安全性之上市後研究
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試驗申請者
台灣東洋藥品工業股份有限公司
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試驗委託 / 贊助單位名稱
台灣東洋藥品工業股份有限公司
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臨床試驗規模
台灣多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
試驗目的
藥品名稱
主成份
劑型
劑量
評估指標
多粘菌素 B 群體之臨床反應率
2. 在 TOC 時，兩個治療群體的臨床反應率
3. 在 TOC 時，依感染部位和感染病原體評估多粘菌素 B 群體之微生物反應率
4. 在 TOC 時，兩個治療群體的微生物反應率
5. 在第 28 天時，兩個治療群體的全因性死亡率
6. 在第 28 天時，兩個治療群體的感染相關死亡率
主要納入條件
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.
主要排除條件
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.
試驗計畫預計收納受試者人數
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台灣人數
480 人
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全球人數
480 人
