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

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ClinicalTrials.gov Identifier: NCT03091439
Recruitment Status : Terminated (Business decision outlined by the corporation.)
First Posted : March 27, 2017
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Osteomyelitis Drug: Dalbavancin Drug: Standard of Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

Arm Intervention/treatment
Experimental: Dalbavancin
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Drug: Dalbavancin
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Other Names:
  • Dalvance®
  • Xydalba™

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population [ Time Frame: Baseline (Day 0) to Day 28 ]
    Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.

  2. Number of Participants With Clinical Improvement at Day 28 in the CE Population [ Time Frame: Baseline (Day 0) to Day 28 ]
    Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.

  3. Number of Participants With Clinical Response at Day 42 in the mITT 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.

  4. Number of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) 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.

  5. Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations [ Time Frame: Day 180 ]
    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.

  6. Number of Participants With Clinical Response at Day 365 in the mITT and CE Populations [ Time Frame: Day 365 ]
    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.

  7. Number of Participants With Clinical Response by Pathogen at Day 42 in the 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.

  8. Number of Participants With Clinical Response by Pathogen at Day 180 in the CE Population [ Time Frame: Day 180 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091439


Locations
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United States, Florida
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Urania Rappo, MD Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03091439     History of Changes
Other Study ID Numbers: 3026-201-008
First Posted: March 27, 2017    Key Record Dates
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Osteomyelitis
dalbavancin
antibiotic
Additional relevant MeSH terms:
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Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Dalbavancin
Teicoplanin
Anti-Infective Agents