WithdrawnPhase 3

Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

0Started 2016-03

Plain-language summary

Dalbavancin for Pediatric Osteomyelitis

Age range2 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Number of patients with clinical improvement at Day 8

Timeframe: Day 8

NCT IDNCT02344511

SponsorDurata Therapeutics International BV (an Affiliate of Actavis, Inc.)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10

Who can participate

Age range2 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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