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

Launched by TTY BIOPHARM · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe two antibiotics, polymyxin B and colistin methanesulfonate, are for treating serious infections caused by certain bacteria that are resistant to common antibiotics, known as carbapenem-resistant Gram-negative bacteria. The study will review the health outcomes of patients who have conditions like bacterial pneumonia or bacteremia (a severe infection in the bloodstream) and who have received these antibiotics for at least 72 hours. Researchers will also analyze how well these treatments work based on where the infection is located in the body and the type of bacteria involved.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with a serious infection caused by these resistant bacteria, excluding urinary tract infections. Participants will be monitored for their health responses to the treatment, any side effects, and overall outcomes. It’s important to note that this study is not yet recruiting participants, so it may be a while before anyone can enroll.

Gender

ALL

Eligibility 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.