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Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis (AHOM)

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ClinicalTrials.gov Identifier: NCT02344511
Recruitment Status : Withdrawn
First Posted : January 26, 2015
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Durata Therapeutics Inc., an affiliate of Allergan plc ( Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) )

Tracking Information
First Submitted Date  ICMJE January 10, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2015)
Number of patients with clinical improvement at Day 8 [ Time Frame: Day 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02344511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2015)
  • Number of clinical responders [ Time Frame: Day 8 ]
  • Average reduction in C-reactive Protein (CRP) relative to the highest value [ Time Frame: Day 8 ]
  • Number of clinical responders by pathogen [ Time Frame: Day 8 ]
  • Number of Participants with Adverse Events [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis
Official Title  ICMJE 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
Brief Summary Dalbavancin for Pediatric Osteomyelitis
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteomyelitis
Intervention  ICMJE
  • Drug: Dalbavancin
    Drug
    Other Name: Dalvance
  • Drug: cefazolin, nafcillin, oxacillin or vancomycin
    Standard of Care
Study Arms  ICMJE
  • Experimental: Dalbavancin

    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.

    Intervention: Drug: Dalbavancin
  • Active Comparator: 4 Comparators

    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).

    Intervention: Drug: cefazolin, nafcillin, oxacillin or vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 22, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2015)
285
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02344511
Other Study ID Numbers  ICMJE DUR001-304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Durata Therapeutics Inc., an affiliate of Allergan plc ( Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) )
Study Sponsor  ICMJE Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alena Jamdourek, MD Durata Therapeutics Inc., an affiliate of Allergan plc
PRS Account Durata Therapeutics Inc., an affiliate of Allergan plc
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP