Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

Osteomyelitis Clinical Trial

— AHOM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02344511
• Other study ID #: DUR001-304
• Status: Withdrawn
• Phase: Phase 3
• First received: January 10, 2015
• Last updated: September 22, 2016
• Start date: March 2016
• Est. completion date: April 2019

Study information

• Verified date: September 2016
• Source: Durata Therapeutics Inc., an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Dalbavancin for Pediatric Osteomyelitis

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteomyelitis

Intervention

Drug:
• Dalbavancin
Drug
• cefazolin, nafcillin, oxacillin or vancomycin
Standard of Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with clinical improvement at Day 8		Day 8	No
Secondary	Number of clinical responders		Day 8	No
Secondary	Average reduction in C-reactive Protein (CRP) relative to the highest value		Day 8	No
Secondary	Number of clinical responders by pathogen		Day 8	No
Secondary	Number of Participants with Adverse Events		6 months	No