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A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP

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ClinicalTrials.gov Identifier: NCT02205112
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Nemonoxacin Drug: Levofloxacin Phase 3

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 levofloxacin in adult patients with community-acquired pneumonia.

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-Blind, Parallel Comparative, Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin Versus Levofloxain in Treating Adult Patients With CAP
Study Start Date : June 2014
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days
Drug: Nemonoxacin
Active Comparator: Levofloxacin 500mg
Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days
Drug: Levofloxacin



Primary Outcome Measures :
  1. Per subject clinical cure rate [ Time Frame: end of treatment and 7 to 14 days after the end of treatment ]
    The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray


Secondary Outcome Measures :
  1. Per subject microbiological cure rate [ Time Frame: end of treatment and 7 to 14 days after the end of treatment ]
    The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory

  2. Per subject overall cure rate [ Time Frame: end of treatment and 7 to 14 days after the end of treatment ]
    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.

  3. Safety evaluation [ Time Frame: duration of trial ]
    Incidence and severity of AE and changes in safety parameters from baseline



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages between 18 and 80;
  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. Male must use a reliable form of contraception.
  8. Able to receive an intravenous infusion of the drug
  9. Able to provide an adequate sputum and blood samples
  10. Able to provide written informed consent

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. Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within 14 days before enrollment
  4. Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or intersstitial lung disease
  5. Bronchial bostruction (exclusive of COPD), bronchiectasis, cystic fibrosis, known or suspected pneumocystis pneumonia, known or suspected tuberculosis, primary empyema thoracis, lung abscess, known or suspected lung cancer, or lung disease associated with autoimmune disorders.
  6. Medical history of QT prolongation, require the treatment of arrhythmia using class IA or class III drugs, or NYHA functional class >/= III
  7. Clinically significant findings on 12-lead ECG, QTc interval>450ms or potassium is < 3.5 mmol/L or lower limit of normal at Screening
  8. Immunocompromising illness, such as HIV infection
  9. Fatal progressive disease or neurodegenerative diseases that prevent patients from effectively clearing pulmonary secretions
  10. Have medical history of seizure, alcohol or drug abuse, suicide tendency, or psychosis that can effect the compliance
  11. Have diseases that may affect intravenous infusion.
  12. Active hepatitis or decompensated cirrhosis with ascites (Child-Pugh score 10-15/class C);
  13. Renal Insufficiency or creatinine >/= 1.1 ULN within 24 hr before first dose
  14. ALT or AST >/= 3x ULN, or BUN >/= 30 mg/dL within 24 hr before first dose
  15. Neutrophil < 1000 mm3 within 24 hr before first dose
  16. Received systemic antibiotics within 72 hr before first dose
  17. Received probenecid within 24 hr before first dose or require the treatment with probenecid during study
  18. Received quinolones or fluoroquinolones within 14 days before first dose
  19. Received any investigational drugs within 30 days before first dose
  20. Require the treatment with other systemic antibiotics during study
  21. Patients who are being or will be on a long-term medication (over 2 weeks) of steroids (20mg/day)
  22. Medical history of hypersensitivity to any quinolone, fluoroquinolone-associated tendinitis and tendon rupture, or myasthenia gravis
  23. Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data
  24. Participated and received the study medication in previous clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205112


Locations
China
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, China, 200040
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02205112     History of Changes
Other Study ID Numbers: TG-873870-C-6
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by TaiGen Biotechnology Co., Ltd.:
intravenous nemonoxacin
community-acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors