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Principal Investigator


Taipei WanFang Hospital (Managed by Taipei Medical Univeristy) (在職)

Division of Infectious Disease

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

Division of Infectious Disease

更新時間：2023-09-19

李文生Lee, Wen-Sen
  • Principal Investigator
  • Clinical Trial Experience (year) 17 years 9 個月

Recruiting Trial

4Cases

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

李文生

List

24Cases

2009-09-15 - 2010-06-30

Phase IV

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Terminated3Sites

2015-09-01 - 2017-12-31

Phase III

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects with Community-Acquired Bacterial Pneumonia (CABP)

  • Condition/Disease

    The initial targeted indications are serious skin infections (ABSSSI), community acquired lower respiratory tract infections (CABP) and urinary tract infections

  • Test Drug

    Omadacycline (PTK 0796)

Participate Sites
5Sites

Terminated5Sites

2014-02-07 - 2015-07-30

Phase II/III

A Phase 3, multicenter, randomized, double-blind, active controlled study to evaluate the efficacy and safety of IV and oral delafloxacin compared with vancomycin + aztreonam in patients with acute bacterial skin and skin structure infections

  • Condition/Disease

    acute bacterial skin and skin structure infections

  • Test Drug

    Delafloxacin

Participate Sites
7Sites

Terminated7Sites

2012-09-02 - 2014-08-31

Phase III

A Phase III, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections (cIAIs) in Hospitalized Adults

  • Condition/Disease

    Complicated Intra-Abodominal Infections (cIAIs)

  • Test Drug

    CAZ104 (Ceftazidime avibactam)

Participate Sites
6Sites

Terminated6Sites

2017-01-01 - 2020-02-29

Phase III

A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared with Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients with Influenza at High Risk of Influenza Complications

  • Condition/Disease

    Influenza

  • Test Drug

    S-033188

Participate Sites
11Sites

Terminated11Sites

2018-01-01 - 2020-05-01

Phase III

A phase 3, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of Pimodivir combined with standard care treatment in adolescents, adults, and elderly hospitalized patients with influenza A

  • Condition/Disease

    Influenza A Infection

  • Test Drug

    Pimodivir

Participate Sites
5Sites

Terminated4Sites

許超群
Kaohsiung Municipal Gangshan Hospital

未分科

2019-08-22 - 2021-08-25

Phase I

A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHILDREN FROM 3 MONTHS TO LESS THAN 18 YEARS OF AGE WHO ARE HOSPITALIZED AND RECEIVING SYSTEMIC ANTIBIOTIC THERAPY FOR SUSPECTED OR CONFIRMED NOSOCOMIAL PNEUMONIA, INCLUDING VENTILATOR-ASSOCIATED PNEUMONIA

  • Condition/Disease

    Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia

  • Test Drug

    ceftazidime-avibactam

Participate Sites
7Sites

Recruiting7Sites

2017-09-01 - 2019-10-31

Phase III

A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

  • Condition/Disease

    Hospital-acquired Bacterial Pneumonia, Ventilator-associatedBacterial Pneumonia, or Healthcare-associated BacterialPneumonia Caused by Gram-negative Pathogens

  • Test Drug

    S-649266

Participate Sites
4Sites

Terminated4Sites

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

Division of Thoracic Medicine

李文生
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Division of Infectious Disease

2008-09-01 - 2009-06-30

Phase III

  • Condition/Disease

  • Test Drug

Participate Sites
14Sites

Terminated14Sites

2013-11-01 - 2016-06-20

Phase III

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

  • Condition/Disease

    Acute Bacterial Skin and SkinStructure Infections

  • Test Drug

    Tedizolid Phosphate

Participate Sites
7Sites

Study ended7Sites

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