Polymyxin B and Colistin for Carbapenem-Resistant Infections
Data Collection
Collected from past medical records and data - RetrospectiveBacterial Infections and Mycoses+5
+ Bacterial Infections
+ Infections
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding how well two medicines, polymyxin B and colistin methanesulfonate, work and how safe they are for patients dealing with serious infections caused by bacteria that are resistant to common antibiotics called carbapenems. These infections are particularly challenging to treat and pose significant health risks. The study is important as it aims to provide insights into the effectiveness of these treatments, potentially improving outcomes for those affected by these tough bacterial infections. Information is collected about the overall health outcomes, the specific bacteria involved, and how patients' kidney functions might affect treatment. Participants in the study have already received treatment with either polymyxin B or colistin methanesulfonate through intravenous infusions. The study observes and records their medical outcomes, such as survival rates and how well the infection responds to the treatment, up to 28 days after starting the medication. Researchers also assess the safety of the treatments by monitoring any side effects. The study evaluates different aspects, including mortality rates and the effectiveness of the treatments in eliminating the bacteria, and compares these outcomes across different infection sites and bacterial types.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.480 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patient ≥ 18 years of age. 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: 1. Patient with bacteremia caused by urinary tract infection. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives