Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01944774
Status:
COMPLETED
Last Update Posted:
2015-02-18
First Post:
2013-08-26
Brief Title:
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Sponsor:
TaiGen Biotechnology Co Ltd
Organization:
TaiGen Biotechnology Co Ltd
Study Overview
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 CAP
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 PKpharmacodynamic PDare to be determined
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 PKpharmacodynamic PDare to be determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None