Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).

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

Details

• Lead Sponsor: TaiGen Biotechnology Co., Ltd.
• Collaborators: QPS-Qualitix; R&G Pharma Studies Co.,Ltd.
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

1. Ages between 18 and 75;

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

3. Must have a clinical diagnosis of CAP

4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates

5. Patients with PORT/PSI score II, III or IV.

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

7. The patient is able to receive an intravenous infusion of the drug .

Exclusion Criteria:

1. Patients with PORT/PSI score I or VI.

2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.

3. 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)

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

5. Potassium is < 3.5 mmol/L

6. Any known disease that seriously affect the immune system

7. Active hepatitis or decompensated cirrhosis;

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

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