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

Allergan1 site in 1 country1 target enrollmentMay 15, 2017

ConditionsOsteomyelitis

InterventionsDalbavancin Standard of Care

DrugsDalbavancin Standard of Care

Overview

Phase: Phase 2
Intervention: Dalbavancin
Conditions: Osteomyelitis
Sponsor: Allergan
Enrollment: 1
Locations: 1
Primary Endpoint: Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 15, 2017

End Date

August 31, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A diagnosis of osteomyelitis (first episode) defined by:
•Pain or point tenderness upon palpation or probing to bone
•Plain radiograph or Magnetic resonance imaging (MRI) consistent with osteomyelitis (indistinctly marginated edema-like pattern of bone marrow hypointensity on unenhanced T1-weighted sequences, hyperintensity on fat-saturated T2-weighted and Short tau inversion recovery (STIR) sequences and/or abnormal enhancement on gadolinium-enhanced fat-saturated T2-weighted sequences, with or without visible periostitis or cortical bone destruction) OR Gram-positive cocci documented on a baseline Gram-stain from a bone specimen
•Elevated C-reactive protein (CRP) (low sensitivity) above the upper limit of normal (ULN) (reference range for low sensitivity CRP is 3-10 mg/L)
•Subjects must be willing and able, if discharged from the hospital, to return to the hospital or a designated clinic for scheduled visits, treatment, laboratory tests, and other outpatient procedures as required by the protocol.

Exclusion Criteria

•Treatment with an investigational drug within 30 days preceding the first dose of investigational product.
•Receipt of \> 24 hours of potentially effective IV antibacterial therapy for osteomyelitis within 96 hours of randomization, unless the pathogen isolated was documented to be Methicillin-resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
•A prior episode of osteomyelitis, or a failed course of therapy for osteomyelitis.
•Infection associated with a burn wound, with a sacral decubitus ulcer, or with multiple sites of osteomyelitis.
•Septic arthritis that is non-contiguous to osteomyelitis, as diagnosed by isolation of a pathogen from synovial fluid culture.
•Immunosuppression/immune deficiency
•Evidence of Gram-negative bacteria by Gram stain in the absence of Gram-positive organisms.
•Gram-negative bacteremia
•Patients with concomitant endocarditis, necrotizing fasciitis, or prosthetic material at the site of infection at the time of study initiation.
•Infection due to an organism known prior to study entry to not be susceptible to dalbavancin (dalbavancin mean inhibitory concentration \[MIC\] \> 0.25 μg/mL) or vancomycin (vancomycin MIC \> 2 μg/mL).

Arms & Interventions

Dalbavancin

Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.

Intervention: Dalbavancin

Standard of Care

Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment will be 4-6 weeks.

Intervention: Standard of Care

Outcomes

Primary Outcomes

Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population

Time Frame: Day 42

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency. The number of participants in each response category is reported.

Secondary Outcomes

Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population(Baseline (Day 0) to Day 28)
Number of Participants With Clinical Improvement at Day 28 in the CE Population(Baseline (Day 0) to Day 28)
Number of Participants With Clinical Response at Day 42 in the mITT Population(Day 42)
Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations(Day 180)
Number of Participants With Clinical Response at Day 365 in the mITT and CE Populations(Day 365)
Number of Participants With Clinical Response by Pathogen at Day 180 in the CE Population(Day 180)
Number of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population(Day 42)
Number of Participants With Clinical Response by Pathogen at Day 42 in the CE Population(Day 42)