Bacteremia Caused by Gram-Negative BacteriaNCT06966284
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
An observational study of Bacteremia Caused by Gram-Negative Bacteria and Bacterial Pneumonia, run by TTY Biopharm at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia Caused by Gram-Negative Bacteria, Bacterial Pneumonia
- How many people
- 480 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Nov 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Intent-To-Treat (ITT) population 2. Total enrolled population
Who may be able to join
- 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.
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- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Keywords
- polymyxin B sulfate
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experiment: Polymyxin B | Not described | |
| Comparator: colistin methanesulfonate | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate of polymyxin B and CMS treatment groups at TOC
Measured: TOC: End of Treatment + 7 days
Microbiological response rate of polymyxin B and CMS treatment groups at TOC
Measured: TOC: End of Treatment + 7 days
All-cause mortality of of polymyxin B and CMS treatment groups at Day 28
Measured: Day 28 from start of treatment
Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Measured: End of Treatment + 7 days
Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Measured: End of Treatment + 7 days
Infection-related mortality of two treatment groups at Day 28
Measured: Day 28 from start of treatment
Secondary outcomes (10)
Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups
Measured: 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
Measured: 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
Measured: Day 7, Day 14, Day 28, EOT, and TOC
Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups
Measured: 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
Measured: Day 7, Day 14, and EOT
Microbiological response rate (Day 7, Day 14, EOT, and TOC) of polymyxin B group by baseline renal function
Measured: Day 7, Day 14, EOT, and TOC
All-cause mortality (Day 14) of two treatment groups
Measured: 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
Measured: Day 14, Day 28 from start of treatment
Infection-related mortality (Day 14) of two treatment groups
Measured: 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
Measured: Day 14, Day 28 from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start26 Nov 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteremia Caused by Gram-Negative BacteriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966284
- Sponsor's protocol ID
- TTYPX2203
- Status last verified
- Apr 2025
- First submitted
- 2 May 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06966284
- Acronym / sponsor ID
- TTYPX2203
- Keywords
- polymyxin B sulfate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment: Polymyxin B | – | – |
| Comparator: colistin methanesulfonate | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Intent-To-Treat (ITT) population 2. Total enrolled population
Key inclusion criteria (15 listed)
- 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).
- VABP: Acute bacterial pneumonia in a subject receiving mechanical ventilation via an endotracheal (or nasotracheal) tube for a minimum of 48 hours.
- Diagnosis Criteria of BSI/Bacteremia: the BSI/sepsis category included bacteremia or sepsis caused by infections other than HABP/VABP, or UTI:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical response rate of polymyxin B and CMS treatment groups at TOC
Time frame: TOC: End of Treatment + 7 days
Microbiological response rate of polymyxin B and CMS treatment groups at TOC
Time frame: TOC: End of Treatment + 7 days
All-cause mortality of of polymyxin B and CMS treatment groups at Day 28
Time frame: Day 28 from start of treatment
Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Time frame: End of Treatment + 7 days
Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Time frame: End of Treatment + 7 days
Infection-related mortality of two treatment groups at Day 28
Time frame: Day 28 from start of treatment
10 secondary outcomes
Clinical response rate (Day 7, Day 14, Day 28, and EOT) of two treatment groups
Time frame: 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
Time frame: 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
Time frame: Day 7, Day 14, Day 28, EOT, and TOC
Microbiological response rate (Day 7, Day 14, and EOT) of two treatment groups
Time frame: 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
Time frame: Day 7, Day 14, and EOT
Microbiological response rate (Day 7, Day 14, EOT, and TOC) of polymyxin B group by baseline renal function
Time frame: Day 7, Day 14, EOT, and TOC
All-cause mortality (Day 14) of two treatment groups
Time frame: 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
Time frame: Day 14, Day 28 from start of treatment
Infection-related mortality (Day 14) of two treatment groups
Time frame: 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
Time frame: Day 14, Day 28 from start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia Caused by Gram-Negative Bacteria and Bacterial Pneumonia, run by TTY Biopharm at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angel Chen (886 2 26525999 ext. 2227, angel_chen@tty.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate of polymyxin B and CMS treatment groups at TOC (time frame: TOC: End of Treatment + 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.