Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

January 23, 2018 updated by: TaiGen Biotechnology Co., Ltd.

A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and

A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Peking University People's Hospital
      • Beijing, China
        • Zhen Hospital, Capital Medical University Beijing
      • Beijing, China
        • Beijing Chaoyang Hospital, Capital Medical University
      • Beijing, China
        • Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Beijing, China
        • PLA Second Artillery General Hospital
      • Chongqing, China
        • Daping Hospital, Third Military Medical University
      • Fujian, China
        • First Affiliated Hospital of Fujian Medical University
      • Gansu, China
        • Gansu Provincial People's Hospital
      • Guangzhou, China
        • Guangzhou Red Cross Hospital
      • Guangzhou, China
        • Second Affiliated Hospital of Sun Yat-sen
      • Guilin, China
        • Affiliated Hospital of Guilin Medical College
      • Hubei, China
        • Taihe Hospital in Shiyan City, Hubei Province
      • Hunan, China
        • Third Xiangya Hospital, Central South University
      • Jiangxi, China
        • Jiangxi Provincial People's Hospital
      • Jiangxi, China
        • Second Affiliated Hospital of Nanchang University
      • Jinan, China
        • Jinan Central Hospital
      • Liaoning, China
        • Shengjing Hospital of China Medical University
      • Nanjing, China
        • Nanjing General Hospital of Nanjing Military Region
      • Shanghai, China
        • Institute of Antibiotics, Huashan Hospital, Fundan University
      • Shanghai, China
        • Shanghai Pudong New Area, Oriental Hospital
      • Shanghai, China
        • Huashan Hospital ,Fudan University
      • Shanghai, China
        • Shanghai Putuo District Central Hospital
      • Shanghai,, China
        • Institute of Antibiotics,Huashan Hospital ,Fudan University
      • Shanxi, China
        • First Hospital of Shanxi Medical University
      • ShenZhen, China
        • Shenzhen People's Hospital
      • Shenyang, China
        • People's Liberation Army General Hospital of Shenyang Military Region
      • Sichuan, China
        • West China Hospital of Sichuan University (Respiratory)
      • Wenzhou, China
        • Second Affiliated Hospital of Wenzhou Medical College
      • Wuhan, China
        • People's Hospital of Wuhan University
      • Wuhan, China
        • Wuhan General Hospital of PLA Guangzhou Military Region
      • Zhejiang, China
        • First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age of 18~70, BMI ≥ 18 kg/m2
  2. Female patients must avoid pregnancy
  3. Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
  4. Chest X-ray shows inflammatory exudation or infiltration image.
  5. Patients who used antibacterial agents (excluding quinolones) within 72 hours before
  6. The patient's disease condition permits oral administration

Exclusion Criteria:

  1. Patients who have any of bronchiectasis and pulmonary disease.
  2. Hospitalized within 14 days before enrollment
  3. Have a history of allergy to any quinolone or fluoroquinolone antibiotic
  4. Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
  5. Renal, liver insufficiency
  6. Malabsorption syndrome or other gastrointestinal diseases
  7. Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen
  8. Steroids longterm use, the dose is at least 20mg of prednisone daily
  9. Patients under critical condition.
  10. Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
  11. Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
  12. Patients who received chemotherapy or anti-tumor therapy within 6 months
  13. Alcohol abused or drugs banned
  14. Patients who used quinolones within two weeks before enrollment
  15. Donated more than 500ml of blood within 3 months
  16. co-medication of other antibacterial agents required.
  17. by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nemonoxacin 750 mg
Nemonoxacin 750 mg 2 tablets.
Drug: Levofloxacin 500 mg placebol
oral form,,once adily,7~10 days
Active Comparator: Nemonoxacin 500 mg
Nemonoxacin 500 mg 3 tablets
Drug: Levofloxacin 500 mg placebol
oral form,,once adily,7~10 days
Active Comparator: Levofloxacin 500 mg
Drug: Nemonoxacin 3 tablets
oral form,once daily,7~10 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Per subject clinical cure rate
Time Frame: 16days
Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable.
16days
Per subject microbiological cure rate
Time Frame: 16days
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
16days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetic profile of nemonoxacin in CAP subjects
Time Frame: 3days
3days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TaiGen Biotechnology Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TG-873870-C-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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