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

NCT06966284 | Recruiting

• 1 other identifier: TTYPX2203
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteremia Caused by Gram-Negative Bacteria; Bacterial Pneumonia

Keywords

polymyxin B sulfate

Outcome Measures

Primary Outcomes (6)

• Clinical response rate of polymyxin B and CMS treatment groups at TOC

  TOC: End of Treatment + 7 days

• Microbiological response rate of polymyxin B and CMS treatment groups at TOC

  TOC: End of Treatment + 7 days

• All-cause mortality of of polymyxin B and CMS treatment groups at Day 28

  Day 28 from start of treatment

• Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC

  End of Treatment + 7 days

• Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC

  End of Treatment + 7 days

• Infection-related mortality of two treatment groups at Day 28

  Day 28 from start of treatment

Secondary Outcomes (10)

• Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups

  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

  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

  Day 7, Day 14, Day 28, EOT, and TOC

• Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups

  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

  Day 7, Day 14, and EOT

Study Arms (2)

Experiment: Polymyxin B

Comparator: colistin methanesulfonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Intent-To-Treat (ITT) population 2. Total enrolled population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TTY Biopharm: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Angel Chen

CONTACT

886 2 26525999; angel_chen@tty.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 9, 2026

Record last verified: 2025-04

Locations

TW (1)