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Principal Investigator


Taipei Medical University Hospital (在職)

Division of Urology

Division of Infectious Disease

更新時間：2023-09-19

莊涵琄
  • Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

6Cases

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

莊涵琄

List

9Cases

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

2021-09-01 - 2023-04-30

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Recruiting6Sites

Terminated2Sites

2026-07-31 - 2027-12-31

Phase III

Not yet recruiting

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Recruiting2Sites

2025-11-01 - 2026-04-30

Phase II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Terminated4Sites

2022-11-21 - 2023-12-20

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Terminated8Sites

2024-12-01 - 2025-11-04

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Recruiting8Sites

2023-09-01 - 2026-06-30

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting4Sites

Recruiting1Sites

2025-07-31 - 2028-09-01

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Recruiting8Sites

2022-10-01 - 2028-06-22

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
9Sites

Not yet recruiting8Sites

Recruiting1Sites

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