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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01944774
• Date of registration: 26/08/2013
• Prospective Registration: No
• Primary sponsor: TaiGen Biotechnology Co., Ltd.
• Public title: Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
• Scientific 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 (CAP)
• Date of first enrolment: March 2013
• Target sample size: 207
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01944774
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

China, Taiwan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Ages between 18 and 75;

2. Weighs between 40 ~ 100 kg, and BMI = 18 kg/m2;

3. Must have a clinical diagnosis of CAP

4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates

5. Patients with PORT/PSI score II, III or IV.

6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use
adequate birth control)

7. The patient is able to receive an intravenous infusion of the drug .

Exclusion Criteria:

1. Patients with PORT/PSI score I or VI.

2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires
vasopressors.

3. 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)

4. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval

5. Potassium is < 3.5 mmol/L

6. Any known disease that seriously affect the immune system

7. Active hepatitis or decompensated cirrhosis;

8. Have used quinolones or fluoroquinolones within 14 days before enrollment

9. Patients who are being or will be on a long-term medication of steroids



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Drug: Moxifloxacin 400 mg

Drug: Nemonoxacin 650 mg

Drug: Nemonoxacin 500 mg

Primary Outcome(s)

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)]

Secondary Outcome(s)

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 [Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)]

Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)]

Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)]

Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)]

Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)]

Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)]

Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)]

Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)]

Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)]

Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)]

Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population [Time Frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)]

Secondary ID(s)

TG-873870-C-5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

R&G Pharma Studies Co.,Ltd.

QPS-Qualitix

Results

• Results available: Yes
• Date Posted: 18/02/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01944774