Clinical Trials List
2014-05-01 - 2017-12-31
Phase III
Terminated17
ICD-10J18.8
Other pneumonia, unspecified organism
ICD-10J18.9
Pneumonia, unspecified organism
ICD-9486
Pneumonia, organism unspecified
A Multi-center, Randomized, Double-Blind, Double-Dummy, parallel, Controlled, Phase III Clinical Trial Evaluating the Efficacy and Safety of Nemonoxacin Malate Sodium Chloride Injection versus Levofloxacin Sodium Chloride Injection in the Treatment of Adult Community-Acquired Pneumonia.
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Trial Applicant
TaiGen Biotechnology Co., Ltd.
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Sponsor
TaiGen Biotechnology
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳世英 Division of Emergency Medicine
- Un-in Wu Division of Infectious Disease
- Jann-Tay Wang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 游騰仁 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 覃俊士 Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- JENG-SEN TSENG Division of Thoracic Medicine
- 王俊隆 Division of Thoracic Medicine
- Wei- Chang Huang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chia-Cheng Tseng Division of Thoracic Medicine
- 王逸熙 Division of Thoracic Medicine
- 方文豐 Division of Thoracic Medicine
- 蘇茂昌 Division of Thoracic Medicine
- 陳永哲 Division of Thoracic Medicine
- 秦建弘 Division of Thoracic Medicine
- 劉世豐 Division of Thoracic Medicine
- 黃國棟 Division of Thoracic Medicine
- 陳泓丞 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Hao Feng Division of Thoracic Medicine
- 王孝為 Division of Infectious Disease
- Tzu-Tao Chen Division of Thoracic Medicine
- Chih-Cheng Chang Division of Thoracic Medicine
- Hon-Ping Ma Division of Emergency Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- jong rung Tsai Division of Thoracic Medicine
- Chau-Chyun Sheu Division of Thoracic Medicine
- Jen-Yu Hung Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Han-Lin Hsu Division of Infectious Disease
- Wen-Sen Lee Division of Infectious Disease
- Shian-Jiun Lin Division of Infectious Disease
- Chih-Hsin Lee Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
(1) Taiwan: In the CE and ITT population, to evaluate whether the clinical effectiveness of nanofloxacin at visit 4 is not inferior to levofloxacin Saccharin.
(2) China: In the mITT population, to evaluate whether the clinical effectiveness of nanofloxacin at visit 4 is not inferior to levofloxacin.
Secondary endpoints:
(1) Taiwan: In the mITT population, assess whether the clinical effectiveness of nanofloxacin at visit 4 is not inferior to levofloxacin.
China: In the CE and ITT population, to evaluate whether the clinical effectiveness of nanofloxacin at visit 4 is not inferior to levoflox Saccharin.
(2) In the mITT, CE, and ITT population, assess whether the clinical effectiveness of nanofloxacin at visit 3 is not inferior to levoflox Saccharin.
(3) In the mITT, CE, and ITT population, evaluate the infection status of nelofloxacin and levofloxacin at visits 3 and 4
Whether there is a difference in the complete remission rate (according to Table 9, which is in line with the “complete remission of infection condition” in clinical cure), and whether it is not inferior by sex test.
(4) In the b-mITT and BE population, evaluate the microbiological effectiveness of nanofloxacin and levofloxacin at visits 3 and 4
Whether there is a difference in the rate (judgment based on each subject).
(5) List the number of microbiologically valid and ineffective cases of each pathogen at visits 3 and 4 (diagnosed according to each pathogen)
(6) In the b-mITT and BE population, assess the comprehensive recovery rate of nelofloxacin and levofloxacin at visits 3 and 4
Whether there is a difference (judged according to each subject).
(7) List the number of cases of comprehensive recovery and ineffectiveness of each type of bacteria at visit 3 and 4 (judgment based on each type of bacteria).
(8) Compare the mortality of nanofloxacin and levofloxacin at 28±2 days after enrollment.
Inclution Criteria
patient or his/her legal representative;
(2) Age ≥20 and ≤80 years old;
(3) Weight 40-100 kg, and BMI ≥18 kg/m2
(4) Clinically diagnosed as community-acquired pneumonia, and has three or more of the
following signs/symptoms/laboratory tests, but one of them must be e or g： ;
a. Cough or cough increased in severity;
b. Purulent sputum
c. Difficulty breathing or shortness of breath;
d. Chest pain or discomfort;
e. Fever (oral temperature ≥38.0°C, axillary temperature ≥37.5°C or auricular temperature
≥38.5°C) or low temperature (≤35°C)
f. Signs of pulmonary consolidation (abnormal auscultation findings, such as bronchial breathing
sounds and/or localized moist rales);
g. White blood count (WBC) ≥9500/mm3 or <3500/mm3
(5) Chest X-rays or CT scan (examination date must be within 2 days before signing the
informed consent form to the day of administrating the first dose of drug) reveal newly
developed inflammatory exudates consistent with acute pneumonia or new infiltration (there
must be a diagnostic imaging report from the department of radiology)
(6) Provide appropriate sputum, blood, and urine samples for bacterial culture and identification,
which include:
a. Gathering sputum specimens deep in the respiratory tract for microscopic examinations. When
squamous epithelial cells are <10 cells/low power field, and white blood cells are >25 cells/low
power field, the specimen is considered a qualified sputum sample. Sputum bacterial culture will
be performed on qualified sputum samples；
b. Blood and urine samples will be collected for blood culture, serum atypical pathogen testing
and urine specific antigen testing；
(7) Subjects must fall into class 2, 3 or 4 according to the PORT score (please refer to appendix
1)；
(8) Female patients must satisfy one of the following criteria:
a. Post-menopausal for at least one year, or
b. Have undergone surgical sterilization, or
c. Subjects of childbearing potential must satisfy the following criteria：
Before enrollment, the urine pregnancy test is negative, and
Subjects agree to use an approved contraceptive method during the entire study period (i.e.
oral contraceptives, spermicidal agents, condoms, or intrauterine devices). Subjects must
also consent to keep the contraceptive method unchanged during the entire study period
(visit 1-5), and
Breastfeeding is prohibited；
(9) Male patients must use a reliable contraceptive method (using condoms, or the spouses using
any of the above standards) throughout the entire study period (visit 1-5);；
(10) Patients can receive IV drug infusion；
(11) Patients in China are able to be admitted in a hospital throughout the drug administration
period (visit 1 to visit 3), or remain in the hospital for observation for 2 hours after drug
administration. Taiwanese patients must be admitted in a hospital throughout the drug
administration period (visit 1 to visit 3).
Exclusion Criteria
(2) Severe pneumonia patients with one of the following conditions：
a. Invasive mechanical ventilation is needed；
b. Vasopressors are needed due to septic shock；
(3) Infection acquired in a hospital or healthcare facility, or patient who was hospitalized within
14 days before enrollment due to any reason (exception: if the patient lives in a nursing home
and receives simple daily living care, he/she is eligible);
(4) Known simple viral pneumonia, aspiration pneumonia, hospital-acquired pneumonia
(including ventilator associated pneumonia) or interstitial pneumonia;
(5) Patients who currently have, or have had a history of one of the following pulmonary
diseases：
a. Bronchial obstruction, with the exception of chronic obstructive pulmonary disease (COPD)
including bronchial asthma;
b. Bronchiectasis;
c. Cystic fibrosis;
d. Known or suspected Pneumocystis jiroveci (also known as Pneumocystis carinii) pneumonia;
e. Known or suspected active tuberculosis;
f. Pimary empyema;
g. Lung abscess;
h. Kwn or suspected pulmonary tumor;
i. Pulmonary disorder caused by autoimmune disease;
(6) Patients with a history of prolonged QTc intervals requiring class IA (e.g. quinidine or
procainamide) or class III (e.g. amiodarone or sotalol) antiarrhythmic drugs, or patients with
severe cardiac insufficiency [New York Heart Association (NYHA) Heart Failure Symptom
Classification System, NYHA Functional Class ≥ III; please refer to appendix 2];
(7) At screening, the 12-lead electrocardiogram (ECG) shows clinically significant abnormal
findings (exceptions: patients with sinus tachycardia caused by pulmonary infection related high
fever are eligible for enrollment), QTc＞450ms at screening or potassium ion of < 3.5 mmol/L or
below the lower limit of normal (patients with potassium ion of below the lower limit of normal
at screening, however shows normal potassium level at re-examination within 24 hours are not
considered as deviation from the protocol analysis and are eligible for enrollment);
(8) Currently suffering from a disease that seriously affects the immune system, for instance,
human immunodeficiency virus (HIV) infection, hematological malignancy, late-stage solid
cancer, or tumor patients currently receiving chemotherapy or radiotherapy；
(9) Patients with progressive fatal disease or chronic neurological disease that prevents mucus
expectoration from the lungs;
(10) History of epilepsy, history of a mental disorder that may affect protocol compliance, risk of
suicide, or history of alcohol or illicit drug abuse (exception: patients with childhood febrile
convulsion are eligible for enrollment)；
(11) Patients with vascular disease which might affect IV infusion；
(12) Active hepatitis, decompensated cirrhosis with severe ascites (Child-Pugh score of 10 – 15 /
class C) or repeated episodes of hepatic encephalopathy；
(13) Renal insufficiency or serum creatinine ≥ 1.1 times the upper limit of normal (ULN) value
within 24 hours before the first dose of drug；
(14) Within 24 hours before administering the first dose of drug, alanine aminotransferase (ALT)
or aspartate aminotransferase (AST) ≥ 3 times the ULN value; total bilirubin ≥ 1.5 times the
ULN value within 24 hours before the first dose of the drug；
(15) Neutrophil count <1000 /mm3 within 24 hours before the first dose of the drug；
(16) Within 72 hours before the first dose of drug, history of using systemic antibiotics for more
than 24 hours；
(17) Use of probenecid within 72 hours of the first dose of the drug, or requiring probenecid
concomitantly.
(18) History of taking quinolone or fluroquinolone antibiotics within 14 days before the first
dose of drug；
(19) Patients who received other therapeutic investigational drugs within 30 days before the first
dose of drug；
(20) The Investigator determines that, in the duration of the study, concomitant use of systemic
antibiotics will be required for treatment；
(21) Patients who are currently, or will be using long-term corticosteroids (for more than 2
weeks), and the dosage consists of at least 20 mg of prednisone per day or other glucocorticoids
with an equivalent potency；
(22) History of allergic reactions to any quinolone drug, history of musculopathy or
tendinopathy due to quinolone drugs, or history of myasthenia gravis；
(23) Any situation that the Investigator judges that may increase the subject’s risk or interfere
with the clinical trial；
(24) Before enrollment, the patient has already participated in this clinical trial and received the
study drug.
The Estimated Number of Participants
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Taiwan
80 participants
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Global
598 participants
