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

NCT02685033 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DAL-MD-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteomyelitis

Keywords

Osteomyelitis; dalbavancin; antibiotic

Outcome Measures

Primary Outcomes (2)

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

  Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).

  Day 42

• Percentage of Participants With Clinical Response at Day 365 in the CE Population

  Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).

  Day 365

Secondary Outcomes (9)

• Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population

  Baseline to Day 21

• Percentage of Participants With Clinical Improvement at Day 21 in the CE Population

  Baseline to Day 21

• Percentage of Participants With Clinical Response at Day 42 in the mITT Population

  Day 42

• Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population

  Day 42

• Percentage of Participant With Clinical Response at Day 180 in the mITT Population

  Day 180

Study Arms (2)

Dalbavancin

EXPERIMENTAL

Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.

Drug: Dalbavancin

Standard of Care

ACTIVE COMPARATOR

Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.

Drug: Comparator

Interventions

Dalbavancin DRUG

Also known as: Dalvance®, Xydalba™

Dalbavancin

Comparator DRUG

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)
• Participants 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 \[MIC\] \> 0.12 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

• Durata Therapeutics Inc., an affiliate of Allergan plc: lead

Study Sites (1)

Allergan Investigative Site 001

Cherkasy, 18009, Ukraine

Location

Related Publications (1)

• Rappo U, Puttagunta S, Shevchenko V, Shevchenko A, Jandourek A, Gonzalez PL, Suen A, Mas Casullo V, Melnick D, Miceli R, Kovacevic M, De Bock G, Dunne MW. Dalbavancin for the Treatment of Osteomyelitis in Adult Patients: A Randomized Clinical Trial of Efficacy and Safety. Open Forum Infect Dis. 2018 Dec 10;6(1):ofy331. doi: 10.1093/ofid/ofy331. eCollection 2019 Jan.

  PMID: 30648126 DERIVED

MeSH Terms

Conditions

Osteomyelitis

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Urania Rappo, MD, MS, PharmD

  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: February 12, 2016
• First Posted: February 18, 2016
• Study Start: March 15, 2016
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-12

Locations

UA (1)