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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02685033
• Date of registration: 12/02/2016
• Prospective Registration: Yes
• Primary sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
• Public title: Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
• Scientific 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
• Date of first enrolment: March 15, 2016
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02685033
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Ukraine

Contacts

• Name: Urania Rappo, MD, MS, PharmD
• Affiliation: Allergan

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteomyelitis

Intervention(s)

Drug: Comparator

Drug: Dalbavancin

Primary Outcome(s)

Percentage of Participants With Clinical Response at Day 365 in the CE Population [Time Frame: Day 365]

Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population [Time Frame: Day 42]

Secondary Outcome(s)

Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population [Time Frame: Day 42]

Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population [Time Frame: Day 42]

Percentage of Participants With Clinical Improvement at Day 21 in the CE Population [Time Frame: Baseline to Day 21]

Percentage of Participants With Clinical Response at Day 365 in the mITT Population [Time Frame: Day 365]

Percentage of Participants With Clinical Response at Day 42 in the mITT Population [Time Frame: Day 42]

Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population [Time Frame: Day 180]

Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population [Time Frame: Baseline to Day 21]

Percentage of Participant With Clinical Response at Day 180 in the mITT Population [Time Frame: Day 180]

Percentage of Participants With Clinical Response at Day 180 in the CE Population [Time Frame: Day 180]

Secondary ID(s)

DAL-MD-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02685033