Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02685033
Other study ID # DAL-MD-04
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 15, 2016
Est. completion date December 12, 2017

Study information

Verified date December 2018
Source Durata Therapeutics Inc., an affiliate of Allergan plc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 12, 2017
Est. primary completion date December 12, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dalbavancin

Comparator


Locations

Country Name City State
Ukraine Allergan Investigative Site 001 Cherkasy

Sponsors (1)

Lead Sponsor Collaborator
Durata Therapeutics Inc., an affiliate of Allergan plc

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population 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
Primary Percentage of Participants With Clinical Response at Day 365 in the CE Population 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 365
Secondary Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population 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]). Baseline to Day 21
Secondary Percentage of Participants With Clinical Improvement at Day 21 in the CE Population 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]). Baseline to Day 21
Secondary Percentage of Participants With Clinical Response at Day 42 in the mITT Population 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
Secondary Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population 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
Secondary Percentage of Participant With Clinical Response at Day 180 in the mITT Population 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 180
Secondary Percentage of Participants With Clinical Response at Day 180 in the CE Population 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 180
Secondary Percentage of Participants With Clinical Response at Day 365 in the mITT Population 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 365
Secondary Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population 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
Secondary Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population 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 180
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04563325 - Oral-only Antibiotics for Bone and Joint Infections in Children Phase 4
Not yet recruiting NCT06402292 - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute N/A
Completed NCT03846804 - Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections N/A
Active, not recruiting NCT04945434 - Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis N/A
Recruiting NCT06084754 - Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis N/A
Recruiting NCT05177107 - Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis Phase 2
Recruiting NCT04554108 - Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses. N/A
Recruiting NCT02128256 - CERAMENT™|G - Bone Healing and Re-infection Prophylaxis Phase 4
Terminated NCT01612962 - Diagnostic Tests to Help Determine Osteomyelitis N/A
Terminated NCT03091439 - Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis Phase 2
Recruiting NCT04936958 - RETR(Osteomyelitis)
Completed NCT03802552 - Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections Phase 1
Completed NCT03559530 - Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
Completed NCT00324922 - Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis Phase 3
Completed NCT02084147 - PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases N/A
Terminated NCT02099240 - Patients Response to Early Switch To Oral:Osteomyelitis Study Early Phase 1
Withdrawn NCT02344511 - Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Phase 3
Completed NCT00402064 - The Influence of Bisphosphonates in the Oral Cavity in Children N/A
Terminated NCT02168816 - Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis Phase 2
Completed NCT02335905 - Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children Phase 1/Phase 2