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

November 23, 2009 updated by: TaiGen Biotechnology Co., Ltd.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) .

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Benomi, South Africa
        • Benmed/Pentagon Hospital
      • Cape Town, South Africa
        • Meditrials
      • Kimberley, South Africa
        • Private
      • Krugersdorp, South Africa
        • DJW Research
      • Port Elizabeth, South Africa
        • GCT Trial Centre, Mercantile Hospital
      • Potchefstroom, South Africa
        • Private
      • Pretoria, South Africa
        • Bougainville Hospital
      • Scottburgh, South Africa
        • de Villers Clinical Trials
      • Witbank, South Africa
        • Park Medical Centre
    • North West
      • Temba, North West, South Africa
        • GCT at Jubilee Hospital
  • Taiwan
      • Changhua, Taiwan, 114
        • Chang-Hua Christian Hospital
      • Kaohsiung, Taiwan, 114
        • E-DA Hospital
      • Kaoshiung, Taiwan, 114
        • Kaoshiung Medical University Hospital
      • Taichung, Taiwan, 114
        • Cheng Ching Hospital
      • Taichung, Taiwan, 114
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 114
        • Chi-Mei Foundation Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 114
        • Buddhist Taipei Tzu Chi General Hospital
      • Taipei, Taiwan, 114
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 114
        • Chang-Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety evaluation
Clinical Cure Rate

Secondary Outcome Measures

Outcome Measure
Bacteriologic Cure Rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TaiGen Biotechnology Co., Ltd.

Collaborators

Quintiles, Inc.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-873870-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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