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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

Tracking Information
First Submitted Date  ICMJE March 21, 2017
First Posted Date  ICMJE March 27, 2017
Results First Submitted Date  ICMJE August 27, 2018
Results First Posted Date  ICMJE September 26, 2018
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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
Change History Complete list of historical versions of study NCT03091439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • Clinical improvement in the modified intent-to-treat (mITT) and CE Populations [ Time Frame: From Baseline (Day 0) to Day 28 ]
    Clinical improvement at Day 28 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteomyelitis
Intervention  ICMJE
  • Drug: Dalbavancin
    Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
    Other Names:
    • Dalvance®
    • Xydalba™
  • 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.
Study Arms  ICMJE
  • Experimental: Dalbavancin
    Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
    Intervention: Drug: Dalbavancin
  • 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.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
100
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03091439
Other Study ID Numbers  ICMJE 3026-201-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urania Rappo, MD Allergan
PRS Account Allergan
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP