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

This study has been completed.
Sponsor:
Collaborators:
Qualitix Clinical Research Co., Ltd.
Parexel
PPD
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01529476
First received: January 31, 2012
Last updated: June 17, 2013
Last verified: June 2013

January 31, 2012
June 17, 2013
April 2011
August 2012   (final data collection date for primary outcome measure)
Per subject clinical cure rate [ Time Frame: 21days ] [ Designated as safety issue: Yes ]
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
Same as current
Complete list of historical versions of study NCT01529476 on ClinicalTrials.gov Archive Site
  • Safety Evaluation [ Time Frame: 24days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
  • Per subject overall cure rate [ Time Frame: 14days ] [ Designated as safety issue: Yes ]
    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
  • Safety Evaluation [ Time Frame: 24days ] [ Designated as safety issue: Yes ]
    Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
Not Provided
Not Provided
 
Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
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)
  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).

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pneumonia
  • Drug: Levofloxacin
    levofloxacin 500 mg,QD,7~10 days
  • Drug: Nemonoxacin
    Nemonoxacin 500mg,QD,7~10 days
  • Experimental: Nemonoxacin 500 mg
    Intervention: Drug: Nemonoxacin
  • Active Comparator: Levofloxacin 500 mg
    Intervention: Drug: Levofloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Taiwan
 
NCT01529476
TG-873870-C-4
No
TaiGen Biotechnology Co., Ltd.
TaiGen Biotechnology Co., Ltd.
  • Qualitix Clinical Research Co., Ltd.
  • Parexel
  • PPD
Not Provided
TaiGen Biotechnology Co., Ltd.
June 2013

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