Clinical trial NCT01944774: Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Comparative, Phase II Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Versus Moxifloxacin in Treating Adult Patients With Community-Acquired Pneumonia (CAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Keywords: Moxifloxacin
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: QPS-Qualitix
name: R&G Pharma Studies Co.,Ltd.
First posted: 2013-09-18
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Secondary outcomes:
measure: Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
measure: Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
measure: Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
measure: Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
measure: Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
measure: Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
measure: Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
measure: Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
measure: Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
measure: Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
measure: Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
timeFrame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute of Antibiotics, Huashan Hospital, Fundan University
city: Taipei
country: Taiwan
facility: Far eastern memorial hospital
Study officials:
References:
citation: Wu XJ, Zhang J, Guo BN, Zhang YY, Yu JC, Cao GY, Chen YC, Zhu DM, Ye XY, Wu JF, Shi YG, Chang LW, Chang YT, Tsai CY. Pharmacokinetics and pharmacodynamics of multiple-dose intravenous nemonoxacin in healthy Chinese volunteers. Antimicrob Agents Chemother. 2015 Mar;59(3):1446-54. doi: 10.1128/AAC.04039-14. Epub 2014 Dec 22.
citation: Cao GY, Zhang J, Zhang YY, Guo BN, Yu JC, Wu XJ, Chen YC, Wu JF, Shi YG. Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy chinese volunteers. Antimicrob Agents Chemother. 2014 Oct;58(10):6116-21. doi: 10.1128/AAC.02972-14. Epub 2014 Aug 4.