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PneumoniaPhase 2NCT01944774

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

A Phase 2 study testing Nemonoxacin 500 mg, Nemonoxacin 650 mg and Moxifloxacin 400 mg in people with Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 75 years
Conditions the study is for
Pneumonia
What is being tested?
Nemonoxacin 500 mg, Nemonoxacin 650 mg and Moxifloxacin 400 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
2 sitesin 2 countries
Study dates
Mar 2013to Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages between 18 and 75;
  • 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)
  • The patient is able to receive an intravenous infusion of the drug .

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.
  • 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
Show all 9Show fewer
  • 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

2 sites in 2 countries.

2 sites in 2 countries

China1 site

  • Institute of Antibiotics, Huashan Hospital, Fundan University

    Shanghai, 200040

Other trials in China

Taiwan1 site

  • Far eastern memorial hospital

    Taipei

Other trials in Taiwan

About this study

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

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 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.

Conditions
Pneumonia
Being tested
Nemonoxacin 500 mg, Nemonoxacin 650 mg, Moxifloxacin 400 mg
Keywords
Moxifloxacin
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nemonoxacin 500 mgDrug

    Also called Taigexyn infusion solution

    IV Infusion, once daily for 7~14 days

  • Nemonoxacin 650 mgDrug

    Also called Taigexyn infusion solution

    IV Infusion, once daily for 7~14 days

  • Moxifloxacin 400 mgDrug

    Also called Moxifloxacin infusion solution

    IV Infusion, once daily for 7~14 days

Study groups in NCT01944774
Study groupRoleWhat they receive
Nemonoxacin 500 mgExperimentalNemonoxacin 500mg/250mL.
Receives: Drug: Nemonoxacin 500 mg
Nemonoxacin 650 mgExperimentalNemonoxacin 650 mg/325mL
Receives: Drug: Nemonoxacin 650 mg
Moxifloxacin 400 mgActive comparatorMoxifloxacin 400mg/250mL
Receives: Drug: Moxifloxacin 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Secondary outcomes (11)

  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

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

  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

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

  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

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

  4. Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

  5. Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

  6. Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

  7. Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

  8. Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

  9. Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

  10. Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

  11. Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population

    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.

    Measured: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01944774
Sponsor's protocol ID
TG-873870-C-5
Status last verified
Feb 2015
First submitted
26 Aug 2013
Last updated
1 Jul 2025
Data monitoring committee
No

Publications

  • Wu XJ, Zhang J, Guo BN, Zhang YY, Yu JC, Cao GY, Chen YC, Zhu DM, Ye XY, Wu JF, Shi YG, Chang LW, Chang YT, Tsai CY. Pharmacokinetics and pharmacodynamics of multiple-dose intravenous nemonoxacin in healthy Chinese volunteers. Antimicrob Agents Chemother. 2015 Mar;59(3):1446-54. doi: 10.1128/AAC.04039-14. Epub 2014 Dec 22.

    PubMed 25534726

  • Cao GY, Zhang J, Zhang YY, Guo BN, Yu JC, Wu XJ, Chen YC, Wu JF, Shi YG. Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy chinese volunteers. Antimicrob Agents Chemother. 2014 Oct;58(10):6116-21. doi: 10.1128/AAC.02972-14. Epub 2014 Aug 4.

    PubMed 25092690

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nemonoxacin 500 mg, Nemonoxacin 650 mg and Moxifloxacin 400 mg in people with Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 2 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 7 inclusion and 9 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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)). 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 NCT01944774, which also lists 2 linked publications.

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 1 Jul 2025.

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