Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

NCT02344511 | Withdrawn Phase 3 DMC

• 1 other identifier: DUR001-304
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dalbavancin for Pediatric Osteomyelitis

Conditions

Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with clinical improvement at Day 8

  Day 8

Secondary Outcomes (4)

• Number of clinical responders

  Day 8

• Average reduction in C-reactive Protein (CRP) relative to the highest value

  Day 8

• Number of clinical responders by pathogen

  Day 8

• Number of Participants with Adverse Events

  6 months

Study Arms (2)

Dalbavancin

EXPERIMENTAL

Patients with Creatine Clearance (CrCl) greater than 30 mL/min and patients receiving regular hemodialysis or peritoneal dialysis will receive 15 mg/kg Intravenous (IV) dalbavancin over 30 (+/- 5) minutes on Day 1 and on Day 8, not to exceed 1500 mg per administration in children at least 12 years and not to exceed 1000 mg per administration in children less than 12 years of age. • Patients with CrCl \< 30 mL/min who are not receiving regular hemodialysis or peritoneal dialysis will receive 10 mg/kg IV dalbavancin over 30 (+/- 5) minutes on Day 1 and on Day 8, not to exceed 1000 mg per administration in children at least 12 years and not to exceed 750 mg per administration in children less than 12 years of age. Additionally, subjects randomized to the dalbavancin group will receive an IV placebo infusion at times corresponding to comparator group dosage times for the first eight days.

Drug: Dalbavancin

4 Comparators

ACTIVE COMPARATOR

cefazolin, oxacillin, nafcillin or vancomycin according to the commercial label Patients with normal renal function will receive either vancomycin 15 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour) not to exceed a daily total dose of 4000 mg, with dose adjustment based on local standard of care to achieve serum trough concentrations of 10 μg/mL to 20 μg/mL; or cefazolin 25 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour); or nafcillin or oxacillin 50 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour).

Drug: cefazolin, nafcillin, oxacillin or vancomycin

Interventions

Dalbavancin DRUG

Drug

Also known as: Dalvance

Dalbavancin

cefazolin, nafcillin, oxacillin or vancomycin DRUG

Standard of Care

4 Comparators

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female 2-16 yrs
• 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):
• Limb abnormality: Pain, point tenderness upon palpation, motion restriction, loss of function
• Magnetic resonance imaging (MRI) -OR- Gram-positive cocci documented on a Gram-stain from a bone specimen or from blood cultures.
• Elevated C-Reactive Protein (CRP)
• informed consent
• willing and able to comply with the study protocol
• Life Expectancy with appropriate antibiotic therapy and thru study duration

You may not qualify if:

• 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 Methicillin resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
• Evidence of subacute or chronic osteomyelitis including: symptoms \> 2 weeks in duration
• 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
• Immunosuppression/immune deficiency
• Evidence of Gram-negative bacteria by gram stain in the absence of Gram-positive organisms; fungus or mycobacteria at baseline.
• Gram-negative bacteremia, even in the presence of gram-positive infection or gram-positive bacteremia.
• A history of oral ulcers preceding the onset of musculoskeletal findings, recent gastrointestinal surgery (within 2 months)
• 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).
• 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.

Sponsors & Collaborators

• Durata Therapeutics International BV (an Affiliate of Actavis, Inc.): lead

MeSH Terms

Conditions

Osteomyelitis

Interventions

dalbavancin; Cefazolin; Nafcillin; Oxacillin; Vancomycin

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillins; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Alena Jamdourek, MD

  Durata Therapeutics Inc., an affiliate of Allergan plc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2015
• First Posted: January 26, 2015
• Study Start: March 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 23, 2016

Record last verified: 2016-09