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
  Purpose
  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).

Condition Intervention Phase
Pneumonia
Drug: Levofloxacin
Drug: Nemonoxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 540
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nemonoxacin 500 mg Drug: Nemonoxacin
Nemonoxacin 500mg,QD,7~10 days
Active Comparator: Levofloxacin 500 mg Drug: Levofloxacin
levofloxacin 500 mg,QD,7~10 days

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529476

  Show 57 Study Locations
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Qualitix Clinical Research Co., Ltd.
Parexel
PPD
  More Information

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01529476     History of Changes
Other Study ID Numbers: TG-873870-C-4
Study First Received: January 31, 2012
Last Updated: June 17, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by TaiGen Biotechnology Co., Ltd.:
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 22, 2014