h Community-Acquired Pneumonia

Objectives: The primary objective of this study is to evaluate the safety of oral nemonoxacin (500 mg once daily for 7-10 days) in treating elderly patients (aged ≥ 65 years) with communityacquired pneumonia (CAP). The secondary objective is to evaluate the clinical success rate of oral nemonoxacin in the modified intention-to-treat (mITT) population at the End of Treatment or Early Termination Visit. This study will also evaluate the clinical success rate in the intentionto-treat (ITT) and clinically evaluable (CE) populations.

Taigexyn

Nemonoxacin Malate

capsule

250 mg

The investigator will evaluate the efficacy of study drug among the patients, including
infection-associated signs and symptoms, chest X-ray, and clinical efficacy. Evaluation of
the aforementioned is not performed during the subsequent visit(s) if a subject is in any of
the following circumstances:
(1) Lack of post-treatment information, which makes it impossible to evaluate the
efficacy (lost to follow-up, missing, etc);
(2) Use of other systemic antibacterial agents for treating other indications; or
(3) Failure to complete the treatment for at least 3 consecutive days according to the
protocol.

(1) Male and female patients, aged ≥ 65 years;
(2) Must have a documented clinical diagnosis of CAP based on relevant clinical symptoms and signs;
(3) Must have new evidence of inflammatory exudates or infiltrates, which is based upon the Investigator’s assessment by chest X-ray within 48 hours prior to first dose;
(4) The severity of CAP must be mild and suitable for outpatient treatment;
(5) Must be a suitable candidate for oral antibacterial therapy and must be able to swallow study drug intact;
(6) Male patients and their partners must agree to use an accepted method of contraception during study. For female patients, the following conditions are to be met:
 has been postmenopausal for at least 1 year, or surgically incapable of bearing
children, or
 is of childbearing potential, and all of the following conditions are met:
- has a negative serum pregnancy test immediately before study entry
- must agree to use an accepted method of contraception (i.e., oral, injectable, or implanted contraceptive with a barrier method, spermicide and barrier method, or IUD) or abstinence. The patient must agree to continue with the same method throughout the study.
 must not attempt to become pregnant during the study period
 must not be lactating.
(7) Adequate written, voluntary informed consent, approved by the Institutional Review Board or Ethics Committee, from the patient or legal representative, must be obtained prior to the initiation of any study procedures.

1. Patients with CAP that, in the Investigator’s judgment, require hospitalization for any of the following reasons including but not limited to: intravenous antibiotic therapy, supplemental oxygen therapy, fluid or vasopressor therapy, close monitor, or ICU support;
2. Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia, defining as receiving of medical care at nursing home or hospitalization for any reason within 14 days prior to first dose;
3. Suspect of active pulmonary tuberculosis, pulmonary neoplasm, lung abscess, or empyema,
4. Known history of bronchiectasis, concurrent existing of tracheostomy, or other bronchial obstruction except COPD;
5. Absolute neutrophil count < 1500 cells/mm3 at screening;
6. Anticipation of the requirement for other additional treatment with systemic administration of non-study antibiotics for any reason;
7. Decompensated cirrhosis, active hepatitis, ALT or AST ≥3X the upper limit of reference range at screening, or total bilirubin levels ≥1.5X the upper limit of reference range at screening;
8. Documented Calculated Clearance of Cre (CCr) <30ml/min within 3 months or eGFR <30ml/min/1.73m2 at screening.
9. Clinically significant conduction or other abnormality on 12-lead ECG, or QTcF interval>450 msec at screening visit; history of prolonged QTc interval or requiring concomitant medication associated with increased QTc interval (i.e., Class I or Class III antiarrhythmic agents);
10. Malabsorption syndromes or other gastrointestinal disturbances affecting study drug absorption; History of HIV infection;
11. History of hypersensitivity or allergic reaction to any quinolone or fluoroquinolone; history of pathological changes in the muscle tendon caused by quinolones or fluoroquinolones, or history of myasthenia gravis;
12. Treatment with chemotherapeutic agents or oncolytics during the 6 months prior to first dose or anticipated requirement for such agents during the course of the study;
13. History or presence, upon clinical evaluation, of any illness or condition that might affect the safety of study drug administration or evaluability of drug effect based on the Investigator’s discretion, or risk of serious drug interactions because of concomitant drugs;
14. Have received any investigational drug within 30 days prior to first dose.