Clinical trial NCT02685033: Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteomyelitis
Keywords: Osteomyelitis
dalbavancin
antibiotic
Lead sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)
* 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.

Primary outcomes:
measure: Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
timeFrame: Day 42
measure: Percentage of Participants With Clinical Response at Day 365 in the CE Population
timeFrame: Day 365
Secondary outcomes:
measure: Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population
timeFrame: Baseline to Day 21
measure: Percentage of Participants With Clinical Improvement at Day 21 in the CE Population
timeFrame: Baseline to Day 21
measure: Percentage of Participants With Clinical Response at Day 42 in the mITT Population
timeFrame: Day 42
measure: Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
timeFrame: Day 42
measure: Percentage of Participant With Clinical Response at Day 180 in the mITT Population
timeFrame: Day 180
measure: Percentage of Participants With Clinical Response at Day 180 in the CE Population
timeFrame: Day 180
measure: Percentage of Participants With Clinical Response at Day 365 in the mITT Population
timeFrame: Day 365
measure: Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
timeFrame: Day 42
measure: Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
timeFrame: Day 180
Other outcomes:
Locations:
city: Cherkasy
country: Ukraine
facility: Allergan Investigative Site 001
Study officials:
affiliation: Allergan
name: Urania Rappo, MD, MS, PharmD
role: STUDY_DIRECTOR
References:
citation: 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.