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

Not yet recruiting

• Conditions: Bacteremia Caused by Gram-Negative Bacteria; Bacterial Pneumonia

• Registration Number: NCT06966284
• Lead Sponsor: TTY Biopharm

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-07-01
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Microbiological response rate (Day 7, Day 14, EOT, and TOC) of polymyxin B group by baseline renal function	Day 7, Day 14, EOT, and TOC
All-cause mortality (Day 14) of two treatment groups	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	Day 14, Day 28 from start of treatment
Infection-related mortality (Day 14) of two treatment groups	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	Day 14, Day 28 from start of treatment