NCT02679573

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 860 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.

Detailed description

The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of community-acquired bacterial pneumonia compared with moxifloxacin, or linezolid in the case of confirmed MRSA.

Conditions

• Community Acquired Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Delafloxacin	Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
DRUG	Moxifloxacin	Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total
DRUG	Linezolid	Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses

Timeline

• Start date: 2016-12-14
• Primary completion: 2018-07-31
• Completion: 2018-08-07
• First posted: 2016-02-10
• Last updated: 2020-02-27
• Results posted: 2020-02-27

Locations

90 sites across 18 countries: United States, Argentina, Bulgaria, Colombia, Dominican Republic, Georgia, Germany, Hungary, Latvia, Peru, Poland, Romania, Russia, Serbia, Slovenia, South Africa, Spain, Ukraine

Regulatory

• FDA-regulated drug study