Intervention: Daptomycin
Trial phase: Phase 3
ATC code: J01XX09
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Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
Eligibility criteria:
Inclusion Criteria:

Obtain Informed Consent;
Be 1 year to < 18 years old; a stepwise approach will be implemented to gate enrollment as follows: enrollment will begin with children aged 2-17 years; after an external Drug Safety Monitoring Board (DSMB) review, enrollment will be broadened to 1-17 years.
Have diagnosis of suspected or confirmed AHO warranting IV antibacterial therapy as inpatient, based on clinical, imaging and/or microbiological evidence as outlined below:

I. Clinical evidence of fever accompanied by symptoms on the affected limb that include but it is not limited to pain, tenderness on palpation, inflammation, warmth, swelling, difficulty bearing weight, motion restriction, loss of function

II. Radiologic imaging (magnetic resonance imaging [MRI], bone scan, x-ray, or computed tomography [CT] scan) consistent with osteomyelitis OR Microbiological evidence (gram stain, culture or polymerase chain reaction (PCR)) from a bone biopsy or bone aspirate (if available), or blood

III. Laboratory evidence: C-reactive protein (CRP) elevated, Erythrocyte sedimentation rate (ESR) elevated, leukocytosis or leukopenia, immature neutrophils

•Confirmed (I, II, and III) OR suspected (I and III) that must be confirmed post-randomization

Participants will not be allowed into the study if they:

Have documented history of any hypersensitivity or allergic reaction to daptomycin
Have septic arthritis only (without AHO)
Have acute hematogenous osteomyelitis that is located in the spine
Have chronic osteomyelitis (i.e. symptoms of osteomyelitis > 21 days) or osteomyelitis with complications requiring non-routine surgical treatment (i.e. sequestration).
Have major trauma, penetrating trauma (including a puncture wound of the foot), postoperative osteomyelitis, foreign body in or adjacent to affected bone or joint, or other iatrogenic bone or joint infections present at the site of infection
Have acute hematogenous osteomyelitis due to a proven gram-negative organism
Have transient tenosynovitis, juvenile rheumatoid arthritis (JRA), reactive arthritis, bony tumors, and other osteoarticular diseases suspected to be due to a nonbacterial (eg, fungal or mycobacterial) etiology
Receive more than 24 hours of effective intravenous antibacterial therapy for osteomyelitis within 96 hours before randomization unless microbiological or clinical failure is documented
Require any potentially effective concomitant systemic antibacterial therapy for gram-positive infections
Have history of seizures (except febrile seizure of childhood)
Have peripheral neuropathy
Have history of rhabdomyolysis (with the exception of muscle injury due to trauma)
Have Sickle cell anemia
Cannot be assessed clinically during the study
Have any condition (eg, cystic fibrosis, current septic shock) that would make the subject, in the opinion of the Investigator, unsuitable for the study
Have significant reduced creatinine clearance (CrCl) < 50 mL/min/1.73 m2
Have evidence of significant hepatic, hematologic, or immunologic dysfunction
Have Creatine kinase (CK) elevation ≥ 10 × ULN (upper limit of normal) without symptoms or ≥ 5 × ULN with symptoms
If female, must not be pregnant or nursing and if required by age and life style take appropriate measures to not get pregnant during the study.
Have participated in any study involving administration of an investigational agent or device or daptomycin within 30 days
Are unable or unwilling to adhere to the study-specified procedures and restrictions
Has suspected or confirmed pneumonia, empyema, meningitis, or endocarditis.