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Principal Investigator


Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital (在職)

Division of Infectious Disease

更新時間：2023-09-19

李雋元Lee, Chun-Yuan
  • Co-Principal Investigator
  • Clinical Trial Experience (year) -8 years -4 個月

Recruiting Trial

17Cases

篩選

Developmental Phase

  • Phase I

  • Phase I/II

  • Phase II

  • Phase II/III

  • Phase III

  • Phase IV

  • Others

Trial Status

  • Not yet recruiting

  • Active

  • Completed

Recruitment Status

  • Not yet recruiting

  • Recruiting

  • Completed

  • Terminated

  • Stop recruiting

  • Suspended

  • Study ended

Trial scale

  • Multi-Regional Multi-Center

  • Taiwan Multiple Center

  • Taiwan Single Center

The expected start time interval of the test

-

Trial Applicant

  • Hospital/Foundation

  • Pharmaceutical/Biopharmaceutical company

  • Contract Research Organization

Important Roles

  • Asia Regional PI

  • Taiwan National PI

  • Chairman/Global PI

  • Steering Committee

  • Advisory board

  • None

Audit by Sponsors/CRO

  • Sponsors

  • CRO

  • None

Investigator-initiated trial(IIT)

  • Yes

Filters

李雋元

List

27Cases

2022-08-25 - 2025-12-19

Phase III

Completed
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
5Sites

Recruiting4Sites

2022-10-01 - 2028-06-22

Phase III

Active
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
9Sites

Not yet recruiting8Sites

Recruiting1Sites

2022-11-01 - 2026-05-31

Phase III

Completed
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
4Sites

Recruiting4Sites

2026-06-01 - 2028-12-31

Phase II

Not yet recruiting
A two-part Phase IIb randomized, multicenter, open-label comparative study to firstly evaluate the safety and efficacy trial of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam, or plus cefiderocol versus best available therapy in patients with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and bloodstream infection, suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii calcoaceticus complex (CRABC), and secondly to evaluate the pharmacokinetics of BV100 in combination with low dose polymyxin B plus cefiderocol in patients with confirmed CRABC ventriculitis or meningitis.

  • Condition/Disease

    Ventilator Associated Bacterial Pneumonia (VABP) Hospital Acquired Bacterial Pneumonia (HABP) Blood Stream Infection Meningitis, Bacterial Ventriculitis, Infectious

  • Test Drug

    Aztreonam BV100 FETROJA Polymyxin B Zavicefta

Participate Sites
9Sites

Not yet recruiting1Sites

2024-12-01 - 2025-11-04

Phase III

Completed
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
8Sites

Recruiting8Sites

2025-01-01 - 2031-01-26

Phase III

Active
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
5Sites

Recruiting5Sites

2025-01-01 - 2031-01-26

Phase III

Active
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
5Sites

Recruiting5Sites

2025-01-01 - 2031-01-26

Phase III

Active
-

  • Condition/Disease

    -

  • Test Drug

    -

Participate Sites
5Sites

Recruiting5Sites

2025-09-01 - 2029-12-31

Not yet recruiting
A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age

  • Condition/Disease

    Healthy

  • Test Drug

    注射劑 注射劑

Participate Sites
6Sites

Recruiting6Sites

2025-03-31 - 2028-06-30

Active
A retrospective, observational post-marketing study evaluating the efficacy and safety of intravenously administered polymyxin B and colistin methanesulfonate in treating patients with carbapenem-resistant, Gram-negative bacterial infections.

  • Condition/Disease

    1. Clinical response rate of the polymyxin B group assessed by infection site and infectious pathogen at TOC (End of Treatment (EOT) + 7 days). 2. Clinical response rate of the two treatment groups at TOC. 3. Microbiological response rate of the polymyxin B group assessed by infection site and infectious pathogen at TOC. 4. Microbiological response rate of the two treatment groups at TOC. 5. All-cause mortality rate of the two treatment groups at day 28. 6. Infection-related mortality rate of the two treatment groups at day 28.

  • Test Drug

    POLYMYXIN B SULFATE

Participate Sites
13Sites

Recruiting13Sites

1 2 3
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