Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01968733
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2013-10-21
Brief Title:
Efficacy and Safety Study of Intravenous to Oral Solithromycin CEM-101 Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Sponsor:
Melinta Therapeutics Inc
Organization:
Melinta Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-Blind Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin CEM-101 Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
Status:
COMPLETED
Status Verified Date:
2017-03
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:
SOLITAIRE-IV
Brief Summary:
This study will evaluate the safety and efficacy of an experimental antibiotic solithromycin in the treatment of adult patients with community-acquired pneumonia
Detailed Description:
Community-acquired bacterial pneumonia CABP is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia chills rigors chest pain andor dyspnea The widespread emergence of antibiotic resistant pathogens including the macrolide-resistant Streptococcus pneumoniae has resulted in a need for new and effective antibiotics that have activity against CABP pathogens Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S pneumoniae and other key typical and atypical bacterial respiratory pathogens A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP
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