NCT01081964

Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

A Phase 2, Multi-Dose, Double-Blind, Double-Dummy, Active-Control, Randomized Study to Evaluate the Safety, Efficacy and Pharmacokinetic Profile of Two Dosing Regimens of Zabofloxacin for the Treatment of Community-Acquired Pneumonia of Moderate Severity

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: IASO Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, three-arm study, to evaluate the safety and efficacy of two dosing regimens of zabofloxacin (a fluoroquinolone antibiotic) in community acquired pneumonia.

Detailed description

The study is a Phase 2, global, prospective, multi-dose, double-blind, double-dummy, active-control, randomized, parallel-group, multicenter study of oral zabofloxacin HCl (400mg) versus oral levofloxacin (500mg) in the treatment of adults with community-acquired pneumonia of moderate severity.

Conditions

• Community Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Zabofloxacin	Zabofloxacin 400mg capsule once daily for 3 days
DRUG	Levofloxacin 500mg	Levofloxacin 500mg orally for 7 days
DRUG	Zabofloxacin 400mg	Zabofloxacin 400mg orally for 5 days

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2010-03-05
• Last updated: 2012-05-07

Locations

13 sites across 1 country: United States