Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms
Conditions
Interventions
Trade Name: Xydalba
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Dalbavancin
CAS Number: 171500-79-1
Current Sponsor code: Dalbavancin
Other descriptive n
Sponsors
Durata Therapeutic International B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects 2-16 years of age A diagnosis of acute (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment with an investigational drug within 30 days preceding the first dose of study medication. Receipt of > 24 hours of potentially effective intravenous antibacterial therapy for AHOM within 96 hours before randomization, unless the pathogen isolated was documented to be MRSA that was resistant to the administered antibiotic. Evidence of subacute or chronic osteomyelitis including: symptoms > 2 weeks in duration, sinus tract with/without purulent drainage, or radiographic evidence of periosteal reaction or sequestrum AHOM of non-long bones (e.g., pelvis or spine) Extraosseous findings such as: subperiosteal abscess, pyomyositis, venous thrombosis, or pulmonary embolism Previous history of septic arthritis or osteomyelitis Major trauma, open-fracture, puncture wound of the foot, post-operative osteomyelitis, foreign body in or adjacent to affected bone or joint, or other iatrogenic bone or joint infections present at the site of infection. Septic arthritis that is non-contiguous to osteomyelitis, as diagnosed by isolation of a pathogen from synovial fluid culture Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count 20 mg prednisolone per day or equivalent), chronic granulomatous disease, and known or suspected human immunodeficiency virus (HIV) infection with a CD4 cell count 0.12 µg/mL) or vancomycin (vancomycin MIC > 2 ?g/mL). Concomitant systemic antibacterial therapy for Gram-positive infections (eg, Rifampin, gentamicin). Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study. Sickle cell anemia Cystic fibrosis Known or suspected hypersensitivity to glycopeptide antibiotics. Patients with a rapidly fatal illness, who are not expected to survive for 3 months. Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing). Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions (female subjects to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche [beginning of breast development]). Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study partic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Clinical improvement at Day 8 in the mITT population: improvement in subjective pain and/or point tenderness and/or range of motion or ability to bear weight;Main Objective: To compare clinical improvement at Day 8 of intravenous dalbavancin to that of the comparator regimen (either cefazolin, nafcillin, oxacillin or vancomycin) for the treatment of acute hematogenous osteomyelitis (AHOM) of the long bones known or suspected to be due to Gram-positive organisms in the modified ITT (mITT) population defined as all randomized subjects with a confirmed diagnosis of AHOM (clinical picture and radiologic or microbiologic findings consistent with AHOM), excluding subjects with confirmed culture of Gram-negative organisms from any baseline specimen.;Secondary Objective: To compare clinical response of dalbavancin to the comparator regimen at Day 8 in the intent-to-treat (ITT) and Clinically Evaluable (CE) populations To compare reduction in CRP relative to the highest value in the two treatment groups on Day 8, Day 28, Day 60 and Day 180 in the ITT, modified ITT (mITT) and CE populations To compare clinical response at Day 28, Day 60 and Day 180 of dalbavancin to the comparator regimen in the mITT and CE populations To compare clinical response by pathogen at Day 8, Day 28, Day 60 and Day 180 of dalbavancin to the comparator regimen in the microbiological mITT (micro-mITT) and microbiologically evaluable (ME) populations To compare the safety and tolerability of dalbavancin to that of the comparator regimen in the safety population.;Timepoint(s) of evaluation of this end point: To compare clinical response of dalbavancin to the comparator regimen at Day 8 in the intent-to-treat (ITT) and Clinically Evaluable (CE) populations To compare reduction in CRP relative to the highest value in the two treatment groups on Day 8, Day 28, Day 60 and Day 180 in the ITT, modified ITT (mITT) and CE populations To compare clinical response at Day 28, Day 60 and Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical response at Day 8 in the ITT and Clinically Evaluable (CE) populations Reduction in CRP (percent reduction) relative to the highest value in the two treatment groups on Day 8, Day 28, Day 60 and Day 180 in the ITT, mITT and CE populations Clinical response at Day 28, Day 60, and Day 180 in the mITT and CE populations Clinical response by pathogen at Day 8, Day 28, Day 60 and Day 180 in the micro-mITT and ME populations;Timepoint(s) of evaluation of this end point: An interim analysis for sample size re-estimation will be performed when early clinical response data at Day 8 are available for approximately 60% of the patients (171 patients). | — |
Countries
Czech Republic, France, Italy, Romania, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactDirector Clinical & Medical Affairs
Durata Therapeutics International B.V.
Outcome results
None listed