Community-acquired PneumoniaPhase 3NCT02205112
A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP
A Phase 3 study testing Nemonoxacin and Levofloxacin in people with Community-acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 63 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Nemonoxacin and Levofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 63 sitesin 2 countries
- Study dates
- Jun 2014to 15 May 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 80;
- 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)
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- Male must use a reliable form of contraception.
- Able to receive an intravenous infusion of the drug
- Able to provide an adequate sputum and blood samples
- Able to provide written informed consent
Who cannot join
- Patients with PORT/PSI score I or VI.
- Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
- Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within 14 days before enrollment
- Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or intersstitial lung disease
- 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.
- Medical history of QT prolongation, require the treatment of arrhythmia using class IA or class III drugs, or NYHA functional class >/= III
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- Clinically significant findings on 12-lead ECG, QTc interval>450ms or potassium is < 3.5 mmol/L or lower limit of normal at Screening
- Immunocompromising illness, such as HIV infection
- Fatal progressive disease or neurodegenerative diseases that prevent patients from effectively clearing pulmonary secretions
- Have medical history of seizure, alcohol or drug abuse, suicide tendency, or psychosis that can effect the compliance
- Have diseases that may affect intravenous infusion.
- Active hepatitis or decompensated cirrhosis with ascites (Child-Pugh score 10-15/class C);
- Renal Insufficiency or creatinine >/= 1.1 ULN within 24 hr before first dose
- ALT or AST >/= 3x ULN, or BUN >/= 30 mg/dL within 24 hr before first dose
- Neutrophil < 1000 mm3 within 24 hr before first dose
- Received systemic antibiotics within 72 hr before first dose
- Received probenecid within 24 hr before first dose or require the treatment with probenecid during study
- Received quinolones or fluoroquinolones within 14 days before first dose
- Received any investigational drugs within 30 days before first dose
- Require the treatment with other systemic antibiotics during study
- Patients who are being or will be on a long-term medication (over 2 weeks) of steroids (20mg/day)
- Medical history of hypersensitivity to any quinolone, fluoroquinolone-associated tendinitis and tendon rupture, or myasthenia gravis
- Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data
- Participated and received the study medication in previous clinical trials
Trial locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
China43 sites
Baotou Central Hospital
Baotou
Aerospace Center Hospital
Beijing
Affiliated Beijing Anzhen Hospital of Capital Medical University
Beijing
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing
Chinese People's Liberation Army General Hospital
Beijing
Institute of Clinical Pharmacology, Peking University
Beijing
Peking University People's Hospital
Beijing
Changsha Central Hospital
Changsha
The Third Changsha Hotpital
Changsha
The Third Xiangya Hospital of Central South University
Changsha
Daping Hospital
Chongqing
Guangxi Zhuang Autonomous Region People's Hospital
Guangxi
First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guilin Medical School Affiliated Hospital
Guilin
Hainan General Hospital
Haikou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou
The Second Affiliated Hospital of Zhejiang University
Hangzhou
The First Hospital of Anhui Medical University
Hefei
The Affilated Hospital of Inner Mongolia Medical University
Hohhot
The First Hospital of Jilin University
Jilin City
The Fourth Hospital of Jilin University
Jilin City
Jinan Central Hospital
Jinan
The Second Hospital of Shandong University
Jinan
Gansu Provincial People's Hospital
Lanzhou
Jiangxi Provincial People's Hospital
Nanchang
Second Subsidiary Hospital of Nanchang Medical College
Nanchang
General Hospital of Nanjing Military Command
Nanjing
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, 200040
Huadong Hospital Affiliated to Fudan University
Shanghai
Shanghai East Hospital of Tongji University
Shanghai
Shanghai Pulmonary Hospital
Shanghai
General Hospital of Shenyang Military
Shenyang
Shengjing Hospital
Shenyang
Shenzhen People's Hospital
Shenzhen
The Second People's Hospital of Shenzhen
Shenzhen
General Hospital of Chengdu Military Region
Sichuan
West China Center of Medical Sciences of Sichuan University
Sichuan
First Hospital of Shanxi Medical University
Taiyuan
Wuxi People's Hospital
Wuxi
Tangdu Hospital
Xi'an
The First Affilated Hospital of Xiamen University
Xiamen
Northern Jiangsu People's Hospital
Yangzhou
The First Affiliated Hospital,College of Medicine,Zhejiang University
Zhejiang
Taiwan20 sites
Changhua Christian Hospital
Chang-hua
Chiayi Chang Gung Memorial Hospital
Chiayi City
NTUH Hsin-Chu Branch
Hsinchu
Hualien Tzu Chi Hospital
Hualien City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Keelung Chang Gung Memorial Hospital
Keelung
Far Eastern Memorial Hospital
New Taipei City
MacKay Memorial Hospital
New Taipei City
China Medical University Hospital
Taichung
Chung Shan Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Chi Mei Hospital, Liouying
Tainan
National Taiwan University Hospital
Taipei
Taipei Medical University - Shuang Ho Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Municipal Wanfang Hospital
Taipei
Tri-Service General Hospital
Taipei
NTUH Yun-Lin Branch
Yuli
About this study
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
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).
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 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Nemonoxacin, Levofloxacin
- Keywords
- intravenous nemonoxacin, community-acquired pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemonoxacinDrug
LevofloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin 500 mg | Experimental | Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days Receives: Drug: Nemonoxacin |
| Levofloxacin 500mg | Active comparator | Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days 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: end of treatment and 7 to 14 days after the end of treatment
Secondary outcomes (3)
Per subject microbiological cure rate
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Measured: end of treatment and 7 to 14 days after the end of treatment
Per subject overall cure rate
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Measured: end of treatment and 7 to 14 days after the end of treatment
Safety evaluation
Incidence and severity of AE and changes in safety parameters from baseline
Measured: duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion4 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired 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
- Participant, Investigator
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205112
- Sponsor's protocol ID
- TG-873870-C-6
- Status last verified
- Oct 2021
- First submitted
- 27 Jul 2014
- Last updated
- 25 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02205112
- Acronym / sponsor ID
- TG-873870-C-6
- Conditions
- Community-acquired Pneumonia
- Keywords
- intravenous nemonoxacin, community-acquired pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 31 Jul 2014 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin 500 mg | Experimental | Drug: NemonoxacinNemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days |
| Levofloxacin 500mg | Active comparator | Drug: LevofloxacinLevofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages between 18 and 80;
- 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.
Key exclusion criteria (24 listed)
- Patients with PORT/PSI score I or VI.
- Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
- Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within 14 days before enrollment
- Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or intersstitial lung disease
- 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.
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 |
|---|---|---|
| Nemonoxacin | Drug | Nemonoxacin 500 mg |
| Levofloxacin | Drug | Levofloxacin 500mg |
Primary outcome
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
3 secondary outcomes
Per subject microbiological cure rate
Time frame: end of treatment and 7 to 14 days after the end of treatment
Per subject overall cure rate
Time frame: end of treatment and 7 to 14 days after the end of treatment
Safety evaluation
Time frame: duration of trial
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 25 Oct 2021.
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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.
63 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 Nemonoxacin and Levofloxacin in people with Community-acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 63 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 10 inclusion and 24 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 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 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: end of treatment and 7 to 14 days after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2021.