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

Primary Purpose

Community-Acquired Pneumonia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TG-873870(Nemonoxacin)

About this trial

This is an interventional treatment trial for Community-Acquired Pneumonia focused on measuring Community-acquired Pneumonia, fluoroquinolone, TG-873870, Nemonoxacin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Safety evaluation

Clinical Cure Rate

Secondary Outcome Measures

Bacteriologic Cure Rate

Full Information

NCT ID

NCT00434291

First Posted

February 12, 2007

Last Updated

November 23, 2009

Sponsor

TaiGen Biotechnology Co., Ltd.

Collaborators

Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00434291

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

TaiGen Biotechnology Co., Ltd.

Collaborators

Quintiles, Inc.

4. Oversight

5. Study Description

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)

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Community-Acquired Pneumonia

Keywords

Community-acquired Pneumonia, fluoroquinolone, TG-873870, Nemonoxacin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

TG-873870(Nemonoxacin)

Primary Outcome Measure Information:

Title

Safety evaluation

Title

Clinical Cure Rate

Secondary Outcome Measure Information:

Title

Bacteriologic Cure Rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: