| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01944774 | Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride | PHASE2 | COMPLETED | 207 | — | — | Mar 1, 2013 | Dec 1, 2013 | Jul 1, 2025 | 2 | China, Taiwan |
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.
| Arm | Type | Description |
|---|---|---|
| Nemonoxacin 500 mg | EXPERIMENTAL | Nemonoxacin 500mg/250mL. |
| Nemonoxacin 650 mg | EXPERIMENTAL | Nemonoxacin 650 mg/325mL |
| Moxifloxacin 400 mg | ACTIVE_COMPARATOR | Moxifloxacin 400mg/250mL |
| Name | Type | Description |
|---|---|---|
| Nemonoxacin 500 mg | DRUG | IV Infusion, once daily for 7\~14 days |
| Nemonoxacin 650 mg | DRUG | IV Infusion, once daily for 7\~14 days |
| Moxifloxacin 400 mg | DRUG | IV Infusion, once daily for 7\~14 days |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | — | Receipt of PCV20 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | — | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | NA | Undisclosed |
| Co-Diagnostics, Inc. | CODX | 1 | — | Undisclosed |