NCT02269644

A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

A Phase 3, Double-blinded, Randomized, Comparator Trial of the Safety and Efficacy of a Single Dose of Dalbavancin to Twice Daily Linezolid for the Treatment of Community Acquired Bacterial Pneumonia

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.

Detailed description

This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of CABP. Adult patients who meet all inclusion and none of the exclusion criteria will be randomized to one of the two treatment arms. Dosing will commence on Day 1, and all patients will receive a minimum of 10 days of therapy. Patients will be assessed on Day 1, Day 4-5, Day 7, Day 14 (End of Therapy, EOT), and Day 28 (Follow up).

Conditions

• Community Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Dalbavancin	dalbavancin 1500 mg IV over 30 minutes on Day 1
DRUG	Linezolid	linezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days
DRUG	Linezolid Placebo	Dalbavancin randomized subjects after Day 1, 1st dose will receive linezolid placebo every 12 hours for a minimum of 10 days and a maximum of 14 days
DRUG	Azithromycin	Dalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2014-10-21
• Last updated: 2016-01-22

Locations

1 site across 1 country: United States