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Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia
This study has been completed.
First Received: February 12, 2007   Last Updated: November 23, 2009   History of Changes
Sponsor: TaiGen Biotechnology Co., Ltd.
Collaborator: Quintiles
Information provided by: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT00434291
  Purpose

This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)


Condition Intervention Phase
Community-Acquired Pneumonia
Drug: TG-873870(Nemonoxacin)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:
  • Safety evaluation
  • Clinical Cure Rate

Secondary Outcome Measures:
  • Bacteriologic Cure Rate

Estimated Enrollment: 264
Study Start Date: December 2006
Study Completion Date: August 2007
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) .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
  • Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact
  • Must have a clinical diagnosis of CAP based on clinical evidence
  • Must have a chest radiograph demonstrating new or persistent/progressive infiltrates
  • Must be able to produce sputum

Exclusion Criteria:

  • Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
  • 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
  • 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)
  • Infection acquired in a hospital, nursing home, or other long-term care facility, or hospitalization for any reason within the previous 14 days
  • Treatment with any antibiotics within the past 7 days prior to randomization, unless documents to be a treatment failure(72 hours treatment and not responding)
  • Anticipation of the requirement for additional treatment with non-study antibacterials for any reason during the patient's participation in the study
  • Treatment with chemotherapeutic agents or oncolytics during the 6 months prior to randomization or anticipated requirement for such agents during the course of the study
  • Known or suspected CNS disorder that may predispose the patient to seizures or lower the seizure threshold
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434291

Locations
South Africa
Bougainville Hospital
Pretoria, South Africa
de Villers Clinical Trials
Scottburgh, South Africa
GCT Trial Centre, Mercantile Hospital
Port Elizabeth, South Africa
Private
Potchefstroom, South Africa
Park Medical Centre
Witbank, South Africa
DJW Research
Krugersdorp, South Africa
Benmed/Pentagon Hospital
Benomi, South Africa
Private
Kimberley, South Africa
MediTrials
Cape Town, South Africa
South Africa, North West
GCT at Jubilee Hospital
Temba, North West, South Africa
Taiwan
E-Da Hospital
Kaohsiung, Taiwan, 114
Chang-Hua Christian Hospital
Changhua, Taiwan, 114
Tri-Service General Hospital
Taipei, Taiwan, 114
Taichung Veterans General Hospital
Taichung, Taiwan, 114
Kaoshiung Medical University Hospital
Kaoshiung, Taiwan, 114
Cheng Ching Hospital
Taichung, Taiwan, 114
Chi-Mei Foundation Hospital
Tainan, Taiwan, 114
Chang-Gung Memorial Hospital
Taoyuan, Taiwan, 114
Buddhist Taipei Tzu Chi General Hospital
Taipei, Taiwan, 114
Taipei Veterans General Hospital
Taipei, Taiwan, 114
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Quintiles
Investigators
Principal Investigator: Reury-Perng Perng, Doctor Taipei Veterans General Hospital, Taipei, Taiwan
Principal Investigator: Ming-Lin Ho, Doctor Chang-Hua Christian Hospital, Changhua, Taiwan
Principal Investigator: Wann-Cherng Perng, Doctor Tri-Service General Hospital, Taipei, Taiwan
Principal Investigator: Kai-Ming Chang, Doctor Taichung Veterans General Hospital, Taichung, Taiwan
Principal Investigator: Yen-Hsu Chen, Doctor Kaoshiung Medical University Hospital, Kaoshiung, Taiwan
Principal Investigator: Ren-Guang Wu, Doctor Cheng Ching Hospital, Taichung, Taiwan
Principal Investigator: Yin-Ching Chuang, Doctor Chi-Mei Foundation Hospital, Tainan, Taiwan
Principal Investigator: Horng-Chyuan Lin, Doctor Chang-Gung Memorial Hospital, Taoyuan, Taiwan
Principal Investigator: Yao-Kuang Wu, Doctor Buddhist Taipei Tzu Chi General Hospital, Taipei, Taiwan
Principal Investigator: Hsi-Hsun Lin, Doctor E-Da Hospital, Kaohsiung, Taiwan
Principal Investigator: AJ Bester, Doctor GCT at Jubilee Hospital, RSA
Principal Investigator: J Breedt, Doctor Bougainville Hospital, RSA
Principal Investigator: CT de Villiers, Doctor de Villers Clinical Trials, RSA
Principal Investigator: M Gani, Doctor GCT Trial Centre, Mercantile Hospital, RSA
Principal Investigator: Y Kelfkens, Doctor Private, RSA
Principal Investigator: DJ Jansen van Rensburg, Doctor Park Medical Centre, RSA
Principal Investigator: J Jurgens, Doctor DJW Research, RSA
Principal Investigator: IH Mitha, Doctor Benmed/Pentagon Hospital, RSA
Principal Investigator: JH Mynhardt, Doctor Private, RSA
Principal Investigator: G Nieuwoudt, Doctor MediTrials, RSA
Principal Investigator: J Kasumba, Doctor JOSHA Research, RSA
Principal Investigator: E van Nieuwenhuizen, Doctor Eastmed Clinical Trial Center, RSA
Principal Investigator: CJJ van Rensburg, Doctor Private, RSA
  More Information

Additional Information:
NCBI  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: TG-873870-02
Study First Received: February 12, 2007
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00434291     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by TaiGen Biotechnology Co., Ltd.:
Community-acquired Pneumonia
fluoroquinolone
TG-873870
Nemonoxacin

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

ClinicalTrials.gov processed this record on February 08, 2010