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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TaiGen Biotechnology Co., Ltd.
• Collaborator: Quintiles, Inc.
• Treatments: Levofloxacin; Ofloxacin

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