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Principal Investigator


Kaohsiung Veterans General Hosptial (在職)

Division of Infectious Disease

Division of General Internal Medicine

China Medical University Hospital (在職)

Division of Infectious Disease

更新時間：2023-09-19

施正蓮
  • Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

5Cases

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

施正蓮

List

29Cases

2018-08-01 - 2023-01-31

Phase III

Completed
A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO-Β-LACTAMASE (MBL)

  • Condition/Disease

    SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO -Β-LACTAMASE (MBL)

  • Test Drug

    PF-06947387 (Aztreonam –Avibactam)

Participate Sites
3Sites

Not yet recruiting3Sites

2018-05-01 - 2023-05-17

Phase III

Completed
A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

  • Condition/Disease

    SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

  • Test Drug

    PF-06947387 (Aztreonam –Avibactam)

Participate Sites
7Sites

Not yet recruiting6Sites

Terminated1Sites

2021-02-01 - 2026-06-22

Phase III

Active
ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

  • Condition/Disease

    Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

  • Test Drug

    Amikacin liposome inhalation suspension (ALIS)

Participate Sites
12Sites

Not yet recruiting6Sites

Recruiting2Sites

Terminated4Sites

2025-11-25 - 2027-04-30

Phase II

Not yet recruiting

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Recruiting3Sites

2024-11-15 - 2033-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
9Sites

Recruiting9Sites

2016-08-01 - 2018-12-31

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Terminated7Sites

2024-12-01 - 2025-11-30

Phase III

Completed
A Phase 3, Randomized, Observer‑blind, Active‑control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA‑1083 (SARS‑CoV‑2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age

  • Condition/Disease

    SARS‑CoV‑2 and Influenza

  • Test Drug

    injection

Participate Sites
8Sites

Recruiting8Sites

2022-11-21 - 2023-12-20

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Terminated8Sites

2020-01-03 - 2021-03-08

Phase III

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Efficacy and Safety of AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by S. aureus

  • Condition/Disease

    AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by S. aureus

  • Test Drug

    AR-301 Tosatoxumab

Participate Sites
10Sites

Not yet recruiting9Sites

Recruiting1Sites

2016-10-21 - 2018-11-19

Phase II

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

  • Condition/Disease

    Respiratory Syncytial Virus (RSV)

  • Test Drug

    ALS-008176 (JNJ-64041575)

Participate Sites
6Sites

Terminated6Sites

李岡遠
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Division of Thoracic Medicine

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