Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162286
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-11-30
Brief Title:
A Phase 3b Randomized Double-blind Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP
Sponsor:
Zai Lab Hong Kong Ltd
Organization:
Zai Lab Hong Kong Ltd
Study Overview
Official Title:
A Phase 3b Randomized Double-blind Multi-center Study to Compare the Safety and Efficacy of Omadacycline IVPO to Moxifloxacin IVPO for Treating Adult Subjects With Community-acquired Bacterial Pneumonia CABP
Status:
RECRUITING
Status Verified Date:
2024-06
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:
public
Brief Summary:
The primary objective of the study is to show that in Chinese adults with CABP a course of IVPO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic IVPO moxifloxacin The study is designed as a bridging study to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None