NCT03091439

Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

A Phase 2, Multicenter, Open-label, Randomized, Comparator-controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis Known or Suspected to be Due to Gram-positive Organisms

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will be a multi-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.

Conditions

• Osteomyelitis

Interventions

Type	Name	Description
DRUG	Dalbavancin	Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
DRUG	Standard of Care	Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2017-03-27
• Last updated: 2018-09-26
• Results posted: 2018-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study