Ignite Creation Date:
2024-05-06 @ 7:33 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02559310
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2015-09-22
Brief Title:
Study to Compare Lefamulin to Moxifloxacin With or Without Linezolid for the Treatment of Adults With Pneumonia
Sponsor:
Nabriva Therapeutics AG
Organization:
Nabriva Therapeutics AG
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin BC 3781 Versus Moxifloxacin With or Without Adjunctive Linezolid in Adults With Community-Acquired Bacterial Pneumonia
Status:
COMPLETED
Status Verified Date:
2019-10
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:
LEAP
Brief Summary:
This study evaluates the safety and efficacy of lefamulin a pleuromutilin for the treatment of adults with moderate to severe community-acquired bacterial pneumonia
Detailed Description:
Lefamulin is a potent semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins Both the intravenous IV and oral dosage forms of lefamulin are under investigation in this study Lefamulins in vitro antibacterial profile includes the most important bacterial pathogens causing respiratory tract infection RTI The antibacterial spectrum comprises S pneumoniae H influenzae M catarrhalis the atypical respiratory pathogens L pneumophila C pneumoniae and M pneumoniae S aureus including MRSA and CA-MRSA ß-haemolytic streptococci including S pyogenes and S agalactiae and Enterococcus faecium including vancomycin-resistant enterococci VRE Moreover as demonstrated in cross-resistance studies lefamulin remains active against clinical isolates resistant to the following antimicrobials classes macrolides lincosamides streptogramin B oxazolidinones tetracyclines ß lactams quinolones trimethoprim-sulfametoxazole mupirocin and vancomycin
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