- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02685033
Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
December 11, 2018 updated by: Durata Therapeutics Inc., an affiliate of Allergan plc
A Phase 2, Single-center, 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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cherkasy, Ukraine, 18009
- Allergan Investigative Site 001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
- 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.
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] > 0.12 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
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Experimental: Dalbavancin
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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Time Frame: Day 42
|
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).
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Day 42
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Percentage of Participants With Clinical Response at Day 365 in the CE Population
Time Frame: Day 365
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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).
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Day 365
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population
Time Frame: Baseline to Day 21
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Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein [CRP]).
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Baseline to Day 21
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Percentage of Participants With Clinical Improvement at Day 21 in the CE Population
Time Frame: Baseline to Day 21
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Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein [CRP]).
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Baseline to Day 21
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Percentage of Participants With Clinical Response at Day 42 in the mITT Population
Time Frame: Day 42
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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).
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Day 42
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Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
Time Frame: Day 42
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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).
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Day 42
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Percentage of Participant With Clinical Response at Day 180 in the mITT Population
Time Frame: Day 180
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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).
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Day 180
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Percentage of Participants With Clinical Response at Day 180 in the CE Population
Time Frame: Day 180
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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).
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Day 180
|
Percentage of Participants With Clinical Response at Day 365 in the mITT Population
Time Frame: Day 365
|
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).
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Day 365
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Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Time Frame: Day 42
|
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
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Time Frame: Day 180
|
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).
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Day 180
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Urania Rappo, MD, MS, PharmD, Allergan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2016
Primary Completion (Actual)
December 12, 2017
Study Completion (Actual)
December 12, 2017
Study Registration Dates
First Submitted
February 12, 2016
First Submitted That Met QC Criteria
February 12, 2016
First Posted (Estimate)
February 18, 2016
Study Record Updates
Last Update Posted (Actual)
January 4, 2019
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAL-MD-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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