Community-acquired PneumoniaPhase 2NCT01537250
Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
A Phase 2 study testing Nemonoxacin 3 tablets in people with Community-acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 32 sites in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Nemonoxacin 3 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 32 sitesChina
- Study dates
- Aug 2009to Aug 2010
- Phase
- Phase 2
- 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
- age of 18~70, BMI ≥ 18 kg/m2
- Female patients must avoid pregnancy
- Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
- Chest X-ray shows inflammatory exudation or infiltration image.
- Patients who used antibacterial agents (excluding quinolones) within 72 hours before
- The patient's disease condition permits oral administration
Who cannot join
- Patients who have any of bronchiectasis and pulmonary disease.
- Hospitalized within 14 days before enrollment
- Have a history of allergy to any quinolone or fluoroquinolone antibiotic
- Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
- Renal, liver insufficiency
- Malabsorption syndrome or other gastrointestinal diseases
Show all 17Show fewer
- 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
- Steroids longterm use, the dose is at least 20mg of prednisone daily
- Patients under critical condition.
- Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
- Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
- Patients who received chemotherapy or anti-tumor therapy within 6 months
- Alcohol abused or drugs banned
- Patients who used quinolones within two weeks before enrollment
- Donated more than 500ml of blood within 3 months
- co-medication of other antibacterial agents required.
- by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
PLA Second Artillery General Hospital
Beijing
Zhen Hospital, Capital Medical University Beijing
Beijing
Daping Hospital, Third Military Medical University
Chongqing
First Affiliated Hospital of Fujian Medical University
Fujian
Gansu Provincial People's Hospital
Gansu
Guangzhou Red Cross Hospital
Guangzhou
Second Affiliated Hospital of Sun Yat-sen
Guangzhou
Affiliated Hospital of Guilin Medical College
Guilin
Taihe Hospital in Shiyan City, Hubei Province
Hubei
Third Xiangya Hospital, Central South University
Hunan
Jiangxi Provincial People's Hospital
Jiangxi
Second Affiliated Hospital of Nanchang University
Jiangxi
Jinan Central Hospital
Jinan
Shengjing Hospital of China Medical University
Liaoning
Nanjing General Hospital of Nanjing Military Region
Nanjing
Huashan Hospital ,Fudan University
Shanghai
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai
Institute of Antibiotics,Huashan Hospital ,Fudan University
Shanghai
Shanghai Pudong New Area, Oriental Hospital
Shanghai
Shanghai Putuo District Central Hospital
Shanghai
First Hospital of Shanxi Medical University
Shanxi
People's Liberation Army General Hospital of Shenyang Military Region
Shenyang
Shenzhen People's Hospital
Shenzhen
West China Hospital of Sichuan University (Respiratory)
Sichuan
Second Affiliated Hospital of Wenzhou Medical College
Wenzhou
People's Hospital of Wuhan University
Wuhan
Wuhan General Hospital of PLA Guangzhou Military Region
Wuhan
First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang
About this study
Official title: 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.
Read the 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Levofloxacin 500 mg placebol, Nemonoxacin 3 tablets
- Keywords
- CAP
- 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.
Levofloxacin 500 mg placebolDrug
oral form,,once adily,7~10 days
Levofloxacin 500 mg placebolDrug
oral form,,once adily,7~10 days
Nemonoxacin 3 tabletsDrug
oral form,once daily,7~10 days
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin 750 mg | Active comparator | Nemonoxacin 750 mg 2 tablets. Receives: Drug: Levofloxacin 500 mg placebol |
| Nemonoxacin 500 mg | Active comparator | Nemonoxacin 500 mg 3 tablets Receives: Drug: Levofloxacin 500 mg placebol |
| Levofloxacin 500 mg | Active comparator | Levofloxacin 500 mg Receives: Drug: Nemonoxacin 3 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per subject clinical cure rate
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.
Measured: 16days
Per subject microbiological cure rate
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
Measured: 16days
Secondary outcomes (1)
Pharmacokinetic profile of nemonoxacin in CAP subjects
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yingyuan Zhang, PhD, Principal investigator, Huashan Hospital, Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537250
- Sponsor's protocol ID
- TG-873870-C-3
- Status last verified
- Jan 2018
- First submitted
- 5 Feb 2012
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1.
PubMed 26748734
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01537250
- Acronym / sponsor ID
- TG-873870-C-3
- Conditions
- Community-acquired Pneumonia
- Keywords
- CAP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 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.
The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin 750 mg | Active comparator | Drug: Levofloxacin 500 mg placebolNemonoxacin 750 mg 2 tablets. |
| Nemonoxacin 500 mg | Active comparator | Drug: Levofloxacin 500 mg placebolNemonoxacin 500 mg 3 tablets |
| Levofloxacin 500 mg | Active comparator | Drug: Nemonoxacin 3 tabletsLevofloxacin 500 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age of 18~70, BMI ≥ 18 kg/m2
- Female patients must avoid pregnancy
- Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
- Chest X-ray shows inflammatory exudation or infiltration image.
- Patients who used antibacterial agents (excluding quinolones) within 72 hours before
Key exclusion criteria (17 listed)
- Patients who have any of bronchiectasis and pulmonary disease.
- Hospitalized within 14 days before enrollment
- Have a history of allergy to any quinolone or fluoroquinolone antibiotic
- Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
- Renal, liver insufficiency
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 |
|---|---|---|
| Levofloxacin 500 mg placeboloral form,,once adily,7~10 days | Drug | Nemonoxacin 750 mg |
| Levofloxacin 500 mg placeboloral form,,once adily,7~10 days | Drug | Nemonoxacin 500 mg |
| Nemonoxacin 3 tabletsoral form,once daily,7~10 days | Drug | Levofloxacin 500 mg |
Primary outcome
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.
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.
1 secondary outcome
Pharmacokinetic profile of nemonoxacin in CAP subjects
Time frame: 3days
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 24 Jan 2018.
- Derived from this study: PubMed 26748734Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1.
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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.
Yingyuan Zhang, PhD principal investigator
Huashan Hospital, Fundan University
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nemonoxacin 3 tablets in people with Community-acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 32 sites in China.
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 17 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 16days). The study lists 2 primary outcomes in all. 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 NCT01537250, 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 24 Jan 2018.