A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection

Официальное название

A Retrospective, Observational, Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Infusions Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection

Обзор

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.

Первичные конечные точки

• Clinical response rate of polymyxin B and CMS treatment groups at TOC [Срок оценки: TOC: End of Treatment + 7 days]
• Microbiological response rate of polymyxin B and CMS treatment groups at TOC [Срок оценки: TOC: End of Treatment + 7 days]
• All-cause mortality of of polymyxin B and CMS treatment groups at Day 28 [Срок оценки: Day 28 from start of treatment]
• Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC [Срок оценки: End of Treatment + 7 days]
• Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC [Срок оценки: End of Treatment + 7 days]
• Infection-related mortality of two treatment groups at Day 28 [Срок оценки: Day 28 from start of treatment]

Вторичные конечные точки (10)

• Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Day 7, Day 14, Day 28, EOT, and TOC]
• Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups [Срок оценки: 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 [Срок оценки: Day 7, Day 14, and EOT]
• Microbiological response rate (Day 7, Day 14, EOT, and TOC) of polymyxin B group by baseline renal function [Срок оценки: Day 7, Day 14, EOT, and TOC]
• All-cause mortality (Day 14) of two treatment groups [Срок оценки: 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 [Срок оценки: Day 14, Day 28 from start of treatment]
• Infection-related mortality (Day 14) of two treatment groups [Срок оценки: 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 [Срок оценки: Day 14, Day 28 from start of treatment]

Критерии участия

Критерии включения

• 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.

• ≥ 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.
• 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.

Критерии исключения

• Patient with bacteremia caused by urinary tract infection.
• CR-GNB known to be resistant to polymyxin B or CMS.
• 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.
• Intravenous administration of polymyxin B or colistin more than 28 days.
• Both the treatment efficacy and safety could not be evaluated.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• Tri-Service General Hospital — Taipei

Идентификаторы

NCT: NCT06966284 · TTYPX2203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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