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

TaiGen Biotechnology

Status and phase: Completed; Phase 2

Conditions: Pneumonia

Treatments: Drug: Nemonoxacin 500 mg; Drug: Moxifloxacin 400 mg; Drug: Nemonoxacin 650 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01944774

TG-873870-C-5

Details and patient eligibility

About

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).

Full 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 considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.

This study will Evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with community-acquired pneumonia.

Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.

Enrollment: 207 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 3 patient groups

Nemonoxacin 500 mg

Experimental group

Description:

Nemonoxacin 500mg/250mL.

Treatment:

Drug: Nemonoxacin 500 mg

Nemonoxacin 650 mg

Experimental group

Description:

Nemonoxacin 650 mg/325mL

Treatment:

Drug: Nemonoxacin 650 mg

Moxifloxacin 400 mg

Active Comparator group

Description:

Moxifloxacin 400mg/250mL

Treatment:

Drug: Moxifloxacin 400 mg