PneumoniaPhase 3NCT01529476
Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
A Phase 3 study testing Levofloxacin and Nemonoxacin in people with Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 57 sites in 2 countries.
Trial summary
1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP) 2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Levofloxacin and Nemonoxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 70;
- Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
- Must have a clinical diagnosis of CAP
- Chest X-ray shows new or persist/progressive infiltrates
- If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
- The patient is able to take the drug orally.
Who cannot join
- Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support
- 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)
- 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
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
China42 sites
Anzhen Hospital,Beijing Capital Medical University
Anzhen
Beijing Union Medical College Hospital
Beijing
General Hospital of PLA Second Artillery
Beijing
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
Beijing Chaoyang Hospital
Chaoyang
West China Hospital of Sichuan University,Center for Infection Disease
Chengdu
PLA Third Militrary Medical University,Second Affiliated Hospital
Chongqing
PLA Third Militrary Medical University,Third Affiliated Hospital
Chongqing
The First Affiliated Hospital,Chongqing Medical University
Chongqing
The First Hospital of Fujian Medical University
Fuzhou
People's Hospital of Gansu Province
Gansu
GuangZhou Red Cross Hospital
Guangzhou
Sun Yet-sen Memorial Hospital
Guangzhou
Affilated Hospital of Guilin Medical college
Guilin
Hainan Provincial People's Hospital
Hainan
Hospital Affiliated to Hainan Medical College
Hainan
Hubei General Hospital
Hubei
Taihe Hospital
Hubei
Hunan Provincial People's Hospital
Hunan
Third Xiangya Hospital,Central South University
Hunan
People's Hospital of Jiangxi Province
Jiangxi
Jinan Central Hospital
Jinan
Lanzhou university second hospital
Lanzhou
Shengjing Hospital of China Medical University
Liaoning
Second Affiliated Hospital of Nanchang University
Nanchang
Nanjing Genrak Hospital of Nanjing Millitary Command
Nanjing
Huadong Hospital of Fudan University
Shanghai
Putuo Central Hospital
Shanghai
Shanghai Changzheng Hospital
Shanghai
Shanghai East Hospital in Pudong New Area
Shanghai
Shanghai Sixth People's Hospital
Shanghai
The First Hospital of Shanxi Medical College
Shanxi
PLA General Hospital of Shenyang Military Region
Shenyang
ShenZhen People's Hospital
Shenzhen
Institute of Antibiotics,Huashan Hospital ,Fudan University
Shianghai
Department of Resoiratory Medicine,West China Hospital of Sichuan University
Sichuan
Shuang Ho Hospital
Taipei
The Second Hospital of Wenzhou Medical College
Wenzhou
Wuhan General Hospital of Guangzhou Millitary Command
Wuhan
The First Affiliated Hospital,Xinjiang Medical University
Xinjiang
First Affiliated Hospital,Zhejiang University School of Medicine
Zhejiang
Taiwan15 sites
Chia-Yi Christian Hospital
Chiayi City
E-Da Hospital
Kaohsiung City
Kaohsiung hang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Yuan's General Hospital
Kaohsiung City
ChiMei Medical Hospital-Liuying branch
Liuying
Cheng Ching General Hospital
Taichung
China Medical University Hospital
Taichung
Chung Shan Medical University Hospital
Taichung
Veterans General Hospital-TaiChung
Taichung
Cheng Hsin General Hospital
Taipei
Far-East Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Tri-Service General Hospital
Taipei
Veterans General Hospital-Taipei
Taipei
About this study
Official title: A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP)
- This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
- To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
Read the 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 test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP).
Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
- Conditions
- Pneumonia
- Being tested
- Levofloxacin, Nemonoxacin
- Keywords
- Ofloxacin, Levofloxacin, Ofloxacin hydrochloride
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
levofloxacin 500 mg,QD,7~10 days
NemonoxacinDrug
Nemonoxacin 500mg,QD,7~10 days
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin 500 mg | Experimental | Not described Receives: Drug: Nemonoxacin |
| Levofloxacin 500 mg | Active comparator | Not described Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per subject clinical cure rate
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
Measured: 21days
Secondary outcomes (3)
Safety Evaluation
Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
Measured: 24days
Per subject microbiological cure rate
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Measured: 14 days
Per subject overall cure rate
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qualitix Clinical Research Co., Ltd., Parexel, PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529476
- Sponsor's protocol ID
- TG-873870-C-4
- Status last verified
- Jun 2013
- First submitted
- 31 Jan 2012
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.
PubMed 30181096
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP)
- ClinicalTrials.gov ID
- NCT01529476
- Acronym / sponsor ID
- TG-873870-C-4
- Conditions
- Pneumonia
- Keywords
- Ofloxacin, Levofloxacin, Ofloxacin hydrochloride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Qualitix Clinical Research Co., Ltd., Parexel, PPD Development, LP
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
- To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
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 test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP).
Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin 500 mg | Experimental | Drug: Nemonoxacin |
| Levofloxacin 500 mg | Active comparator | Drug: Levofloxacin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages between 18 and 70;
- Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
- Must have a clinical diagnosis of CAP
- Chest X-ray shows new or persist/progressive infiltrates
- If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
Key exclusion criteria (8 listed)
- Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacinlevofloxacin 500 mg,QD,7~10 days | Drug | Levofloxacin 500 mg |
| NemonoxacinNemonoxacin 500mg,QD,7~10 days | Drug | Nemonoxacin 500 mg |
Primary outcome
Per subject clinical cure rate
Time frame: 21days
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
3 secondary outcomes
Safety Evaluation
Time frame: 24days
Per subject microbiological cure rate
Time frame: 14 days
Per subject overall cure rate
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Derived from this study: PubMed 30181096Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin and Nemonoxacin in people with Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 57 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per subject clinical cure rate (time frame: 21days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01529476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.