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

NCT03091439 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 3026-201-008
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteomyelitis

Keywords

Osteomyelitis; dalbavancin; antibiotic

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 42

Secondary Outcomes (8)

• 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 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population

  Day 42

• Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations

  Day 180

Study Arms (2)

Dalbavancin

EXPERIMENTAL

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

Drug: Dalbavancin

Standard of Care

ACTIVE COMPARATOR

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.

Drug: Standard of Care

Interventions

Dalbavancin DRUG

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

Also known as: Dalvance®, Xydalba™

Dalbavancin

Standard of Care DRUG

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Concomitant systemic antibacterial therapy for Gram-positive infections (eg, rifampin, gentamicin).
• Known or suspected hypersensitivity to glycopeptide antibiotics.
• Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
• Pregnant or nursing females; positive urine (or serum) pregnancy test at Screening (pre-menopausal females only) or after admission (prior to dosing)
• Sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least the first dose of study drug until the last pregnancy test.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

MeSH Terms

Conditions

Osteomyelitis

Interventions

dalbavancin; Standard of Care

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Urania Rappo, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: May 15, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-08

Locations

US (1)