NCT02685033

Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis

A Phase 2, Single-center, 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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will be a single-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
DRUG	Comparator

Timeline

• Start date: 2016-03-15
• Primary completion: 2017-12-12
• Completion: 2017-12-12
• First posted: 2016-02-18
• Last updated: 2019-01-04
• Results posted: 2019-01-04

Locations

1 site across 1 country: Ukraine

Regulatory

• FDA-regulated drug study