Clinical Trial: Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Subjects With Osteomyelitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2, Single-center, Open-label, Randomized, Comparator-controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Subjects With Osteomyeli
Brief 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.
Detailed Summary:
Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Current Primary Outcome: Clinical response in the Clinically Evaluable (CE) population [ Time Frame: At Day 42 ]
Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
- Lost to follow-up
- Amputation due to vascular insufficiency
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical improvement in the modified intent-to-treat (mITT) and CE Populations [ Time Frame: From Baseline (Day 0) to Day 21 ]Clinical improvement at Day 21 is defined as no worsening of pain from baseline, if present, and improvement in inflammation
- Clinical response in the mITT and microbiological modified intent-to-treat (micro-mITT) Populations [ Time Frame: At Day 42 ]
Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
- Lost to follow-up
- Amputation due to vascular insufficiency
- Clinical response at Day 180 in the mITT and CE Populations [ Time Frame: At Day 180 ]
Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
- Lost to follow-up
- Amputation due to vascular insufficiency
- Clinical response at Day 365 in the mITT and CE Populations [ Time Frame: At Day 365 ]
Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
- Lost to follow-up
- Amputation due to vascular insufficiency
- Clinical response by pathogen at Day 42 in the CE Population [ Time Frame: At Day 42 ]
Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
- Lost to follow-up
- Amputation due to vascular insufficiency
- Clinical response by pathogen at Day 180 in the CE Population [ Time Frame: At Day 180 ]
Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
- Lost to follow-up
- Amputation due to vascular insufficiency
Original Secondary Outcome: Same as current
Information By: Durata Therapeutics Inc., an affiliate of Allergan plc
Dates:
Date Received: February 12, 2016
Date Started: March 2016
Date Completion: November 2017
Last Updated: October 18, 2016
Last Verified: October 2016