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Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia

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: NCT00434291
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : November 25, 2009
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by:
TaiGen Biotechnology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Community-Acquired Pneumonia Drug: TG-873870(Nemonoxacin) Phase 2

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) .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : December 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Safety evaluation
  2. Clinical Cure Rate

Secondary Outcome Measures :
  1. Bacteriologic Cure Rate


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434291


Locations
Show Show 20 study locations
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Quintiles, Inc.
Investigators
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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
Additional Information:
NCBI  This link exits the ClinicalTrials.gov site

Publications:
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ClinicalTrials.gov Identifier: NCT00434291    
Other Study ID Numbers: TG-873870-02
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by TaiGen Biotechnology Co., Ltd.:
Community-acquired Pneumonia
fluoroquinolone
TG-873870
Nemonoxacin
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases