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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944774
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Collaborators:
QPS-Qualitix
R&G Pharma Studies Co.,Ltd.
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
Pneumonia Drug: Nemonoxacin 500 mg Drug: Nemonoxacin 650 mg Drug: Moxifloxacin 400 mg Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 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 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 Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL.
Drug: Nemonoxacin 500 mg
IV Infusion, once daily for 7~14 days

Experimental: Nemonoxacin 650 mg
Nemonoxacin 650 mg/325mL
Drug: Nemonoxacin 650 mg
IV Infusion, once daily for 7~14 days

Active Comparator: Moxifloxacin 400 mg
Moxifloxacin 400mg/250mL
Drug: Moxifloxacin 400 mg
IV Infusion, once daily for 7~14 days




Primary Outcome Measures :
  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 [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) ]
    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 CE 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.

  2. Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) ]
    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 3 in the mITT population. At visit 3, 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.

  3. Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) ]
    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 3 in the CE population. At visit 3, 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.

  4. Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) ]

    Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:

    1. Subjects whose respiratory culture from visit 1 was positive;
    2. Subjects whose blood culture from visit 1 was positive.

    The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.


  5. Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) ]

    Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:

    1. Subjects whose respiratory culture from visit 1 was positive;
    2. Subjects whose blood culture from visit 1 was positive.

    The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.


  6. Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) ]

    Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:

    1. Subjects whose respiratory culture from visit 1 was positive;
    2. Subjects whose blood culture from visit 1 was positive.

    The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.


  7. Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) ]

    Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:

    1. Subjects whose respiratory culture from visit 1 was positive;
    2. Subjects whose blood culture from visit 1 was positive.

    The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.


  8. Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) ]
    Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

  9. Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) ]
    Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

  10. Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) ]
    Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

  11. Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population [ Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) ]
    Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01944774


Locations
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China
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, China, 200040
Taiwan
Far eastern memorial hospital
Taipei, Taiwan
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
QPS-Qualitix
R&G Pharma Studies Co.,Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01944774     History of Changes
Other Study ID Numbers: TG-873870-C-5
First Posted: September 18, 2013    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by TaiGen Biotechnology Co., Ltd.:
Moxifloxacin
Additional relevant MeSH terms:
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Moxifloxacin
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs