Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TaiGen Biotechnology Co., Ltd.
• Collaborators: Parexel; PPD; Qualitix Clinical Research Co., Ltd.
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

1. Ages between 18 and 70;

2. Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;

3. Must have a clinical diagnosis of CAP

4. Chest X-ray shows new or persist/progressive infiltrates

5. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)

6. The patient is able to take the drug orally.

Exclusion Criteria:

1. 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

2. 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)

3. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval

4. Potassium is < 3.5 mmol/L

5. Any known disease that seriously affect the immune system

6. Active hepatitis or decompensated cirrhosis;

7. Have used quinolones or fluoroquinolones within 14 days before enrollment

8. Patients who are being or will be on a long-term medication of steroids