Phase 2
N=207
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT01944774 ↗Enrolled (actual)
207
Serious AEs
2.4%
Results posted
Feb 2015
Primary outcome: Primary: Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population — 60; 58; 59; 7 participants — p=0.133
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nemonoxacin 500 mg (Drug); Nemonoxacin 650 mg (Drug); Moxifloxacin 400 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TaiGen Biotechnology Co., Ltd.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population |
60; 58; 59; 7; 4; 2 | 0.133 |
| SECONDARY 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 |
56; 56; 58; 7; 3; 2 | 0.118 |
| SECONDARY Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population |
61; 60; 59; 4; 4; 2 | 0.456 |
| SECONDARY Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population |
58; 56; 56; 4; 3; 2 | 0.458 |
| SECONDARY Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population |
21; 17; 16; 3; 1; 0 | 0.959 |
| SECONDARY Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population |
20; 17; 15; 3; 1; 0 | 0.960 |
| SECONDARY Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population |
22; 18; 16; 2; 1; 0 | 0.950 |
| SECONDARY Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population |
21; 18; 16; 2; 1; 0 | 0.949 |
| SECONDARY Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population |
21; 17; 16; 3; 2; 1 | 0.491 |
| SECONDARY Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population |
20; 17; 15; 3; 2; 1 | 0.501 |
| SECONDARY Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population |
22; 17; 15; 2; 2; 1 | 0.807 |
| SECONDARY Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population |
21; 17; 15; 2; 2; 1 | 0.779 |
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).
Eligibility Criteria
Inclusion Criteria
- 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 .
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01944774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.