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Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01529476
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : June 18, 2013
Sponsor:
Collaborators:
Qualitix Clinical Research Co., Ltd.
Parexel
PPD
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date June 18, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
Per subject clinical cure rate [ Time Frame: 21days ]
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Per subject clinical cure rate [ Time Frame: 21days ]
    The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
  • Per subject microbiological cure rate [ Time Frame: 14days ]
    The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Change History Complete list of historical versions of study NCT01529476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
  • Safety Evaluation [ Time Frame: 24days ]
    Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
  • Per subject microbiological cure rate [ Time Frame: 14 days ]
    The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
  • Per subject overall cure rate [ Time Frame: 14 days ]
    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Per subject overall cure rate [ Time Frame: 14 days ]
    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
  • Safety Evaluation [ Time Frame: 24days ]
    Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
Official Title  ICMJE A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP)
Brief Summary
  1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
  2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
Detailed Description

Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP).

Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • Drug: Levofloxacin
    levofloxacin 500 mg,QD,7~10 days
  • Drug: Nemonoxacin
    Nemonoxacin 500mg,QD,7~10 days
Study Arms  ICMJE
  • Experimental: Nemonoxacin 500 mg
    Intervention: Drug: Nemonoxacin
  • Active Comparator: Levofloxacin 500 mg
    Intervention: Drug: Levofloxacin
Publications * Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2012)
540
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ages between 18 and 70;
  2. Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
  3. Must have a clinical diagnosis of CAP
  4. Chest X-ray shows new or persist/progressive infiltrates
  5. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
  6. The patient is able to take the drug orally.

Exclusion Criteria:

  1. Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support
  2. Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)
  3. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
  4. Potassium is < 3.5 mmol/L
  5. Any known disease that seriously affect the immune system
  6. Active hepatitis or decompensated cirrhosis;
  7. Have used quinolones or fluoroquinolones within 14 days before enrollment
  8. Patients who are being or will be on a long-term medication of steroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529476
Other Study ID Numbers  ICMJE TG-873870-C-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TaiGen Biotechnology Co., Ltd.
Study Sponsor  ICMJE TaiGen Biotechnology Co., Ltd.
Collaborators  ICMJE
  • Qualitix Clinical Research Co., Ltd.
  • Parexel
  • PPD
Investigators  ICMJE Not Provided
PRS Account TaiGen Biotechnology Co., Ltd.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP