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

NCT01944774 | Completed Phase 2 Results

• 1 other identifier: TG-873870-C-5
• Study Type: interventional
• Target: 207
• Locations: 2 countries
• Sites: 2

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).

Conditions

Pneumonia

Keywords

Moxifloxacin

Outcome Measures

Primary Outcomes (1)

• Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population

  The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

  Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Secondary Outcomes (11)

• 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

  Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

• Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population

  Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

• Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population

  Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

• Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population

  Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

• Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population

  Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Study Arms (3)

Nemonoxacin 500 mg

EXPERIMENTAL

Nemonoxacin 500mg/250mL.

Drug: Nemonoxacin 500 mg

Nemonoxacin 650 mg

EXPERIMENTAL

Nemonoxacin 650 mg/325mL

Drug: Nemonoxacin 650 mg

Moxifloxacin 400 mg

ACTIVE COMPARATOR

Moxifloxacin 400mg/250mL

Drug: Moxifloxacin 400 mg

Interventions

Nemonoxacin 500 mg DRUG

IV Infusion, once daily for 7\~14 days

Also known as: Taigexyn infusion solution

Nemonoxacin 500 mg

Nemonoxacin 650 mg DRUG

IV Infusion, once daily for 7\~14 days

Also known as: Taigexyn infusion solution

Nemonoxacin 650 mg

Moxifloxacin 400 mg DRUG

IV Infusion, once daily for 7\~14 days

Also known as: Moxifloxacin infusion solution

Moxifloxacin 400 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 18 and 75;
• Weighs between 40 \~ 100 kg, and BMI ≥ 18 kg/m2;
• Must have a clinical diagnosis of CAP
• Chest X-ray and /or CT scan show new or persist/progressive infiltrates
• Patients with PORT/PSI score II, III or IV.
• If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
• The patient is able to receive an intravenous infusion of the drug .

You may not qualify if:

• Patients with PORT/PSI score I or VI.
• Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
• Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
• Potassium is \< 3.5 mmol/L
• Any known disease that seriously affect the immune system
• Active hepatitis or decompensated cirrhosis;
• Have used quinolones or fluoroquinolones within 14 days before enrollment
• Patients who are being or will be on a long-term medication of steroids

Sponsors & Collaborators

• TaiGen Biotechnology Co., Ltd.: lead
• QPS-Qualitix: collaborator
• R&G Pharma Studies Co.,Ltd.: collaborator

Study Sites (2)

Institute of Antibiotics, Huashan Hospital, Fundan University

Shanghai, 200040, China

Location

Far eastern memorial hospital

Taipei, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 25534726 DERIVED

• 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.

  PMID: 25092690 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

nemonoxacin; Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chen-En Tsai, M.D., Ph.D.
• Organization: TaiGen Biotechnology Co., Ltd.

cetsai@taigenbiotech.com

+886-2-8177-7072

Study Officials

• LiWen Chang

  Taigenbiotech

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 18, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 1, 2025
• Results First Posted: February 18, 2015

Record last verified: 2015-02

Locations

TW (1); CN (1)