Status:
COMPLETED
Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia
Lead Sponsor:
TaiGen Biotechnology Co., Ltd.
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Community-Acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00434291
Start Date
December 1 2006
End Date
August 1 2007
Last Update
November 25 2009
Active Locations (20)
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1
GCT at Jubilee Hospital
Temba, North West, South Africa
2
Benmed/Pentagon Hospital
Benomi, South Africa
3
MediTrials
Cape Town, South Africa
4
Private
Kimberley, South Africa