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