Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms

Dalbavancin for Pediatric Osteomyelitis

A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms.

Inclusion Criteria:

1. Male or female 2-16 yrs
2. diagnosis of Acute Hematogenous Osteomyelitis (AHOM) of the long bones (ulna, radius, femur, tibia) defined by the following clinical signs and symptoms (< 2 weeks in duration; multiple sites of infection within long bones):
3. Limb abnormality: Pain, point tenderness upon palpation, motion restriction, loss of function
4. Magnetic resonance imaging (MRI) -OR- Gram-positive cocci documented on a Gram-stain from a bone specimen or from blood cultures.
5. Elevated C-Reactive Protein (CRP)
6. informed consent
7. willing and able to comply with the study protocol
8. Life Expectancy with appropriate antibiotic therapy and thru study duration

Exclusion Criteria:

1. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
2. 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 Methicillin resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
3. Evidence of subacute or chronic osteomyelitis including: symptoms > 2 weeks in duration
4. AHOM of non-long bones (e.g., pelvis or spine).
5. Extraosseous findings such as: subperiosteal abscess, pyomyositis, venous thrombosis, or pulmonary embolism.
6. Previous history of septic arthritis or osteomyelitis.
7. 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.
8. Septic arthritis that is non-contiguous to osteomyelitis
9. Immunosuppression/immune deficiency
10. Evidence of Gram-negative bacteria by gram stain in the absence of Gram-positive organisms; fungus or mycobacteria at baseline.
11. Gram-negative bacteremia, even in the presence of gram-positive infection or gram-positive bacteremia.
12. A history of oral ulcers preceding the onset of musculoskeletal findings, recent gastrointestinal surgery (within 2 months)
13. Infection due to an organism known prior to study entry to be not susceptible to dalbavancin (dalbavancin mean inhibitory concentration > 0.12 µg/mL) or vancomycin (vancomycin mean inhibitory concentration (MIC) > 2 μg/mL).
14. Concomitant systemic antibacterial therapy for Gram-positive infections (eg. Rifampin, gentamicin).
15. Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
16. Sickle cell anemia.
17. Cystic fibrosis.
18. hypersensitivity to glycopeptide antibiotics.
19. not expected to survive for 3 months.
20. Positive urine (or serum) pregnancy test
21. Women of Child Bearing Potential who are unwilling or unable to use adequate contraceptive precautions.
22. Other severe acute or chronic medical or psychiatric condition would make the patient inappropriate for entry into this study.
23. Unwilling or unable to follow study procedures.