Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)

Clinical improvement was based on the Investigator's overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others.

Time frame: Up to study Day 5

Population: All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen.

At Test Of Cure (TOC) clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further antibacterial therapy is required. Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. To have a favorable microbiological response, the outcome for each participant's baseline pathogen must be favorable (eradicated or presumed eradicated). Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.

Time frame: Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

Population: All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.

Favorable clinical outcomes are clinical recovery and clinical cure. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. Clinical recovery is defined as clinical improvement in the composite end point three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5, and no development of new symptoms of AHO; body temperature ≤ 38°C (100.4°F) for 24 hours; no new or additional bone or joint infection (e.g., abscess, spreading to other osseous or articular locations) such that no further antibacterial therapy or surgery are required; no hematogenous metastatic infection (e.g., abscess in liver, spleen, lung; other bones) or bacteremia.. The End of Therapy (EOT) visit is within 48 hours of last dose of PO therapy.

Time frame: Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

Population: All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen

Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. For a favorable microbiological response, the outcome for each baseline pathogen must be eradicated or presumed eradicated. Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.

Time frame: Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

Population: All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.

A participant had a favorable outcome in this composite endpoint if all 3 of the following criteria were met: Clinical improvement in the general symptom categories of Pain, Inflammation, and Limb Function on or before Study Day 5; Body temperature ≤ 38°C (100.4°F) over the preceding 24 hours; and C-reactive Protein (CRP) decreased from baseline for participants who had a baseline CRP \>ULN (upper limit of normal)) or remain \<=ULN for participants who had a baseline \<=ULN on or before Study Day 5. The EOIV visit is within 24 hours after the last dose of IV study drug and before switch to optional open label (PO) therapy, if applicable.

Time frame: Up to study Day 5

Population: All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen and who did not have all clinical assessments performed at the time point.

Sustained clinical improvement was defined as participants with clinical improvement who further met the definition of clinical cure. Clinical improvement was in the three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. The EOT visit is within 48 hours of last dose of PO therapy.

Time frame: Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

Population: All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen; and had non-missing clinical outcome.

Focused neurological examinations include assessments of alertness, sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk, and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose), and tremor of the hands/fingers.

Time frame: Baseline and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)

Population: Data were only summarized for each visit; but not analyzed.

Serum was collected at Baseline and at End of Therapy IV, from which the concentration of CK was determined.

Time frame: Baseline and End of Therapy IV (up to Day 42)

Population: Treated participants based on the treatment received

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, clinically significant laboratory finding, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

Time frame: Administration of first dose up to approximately six and a half months after last dose of study drug

Population: Treated participants based on the treatment received

An SAE is any untoward medical occurrence that at any dose results in death; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.

Time frame: Administration of first dose through the last follow-up visit; an expected time of up to 6.5 months

Population: Treated participants based on the treatment received

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42

Time frame: Day 3 up to Day 42

Population: Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42

Time frame: Day 3 up to Day 42

Population: Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42

Time frame: Day 3 up to Day 42

Population: Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.

Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42

Time frame: Day 3 up to Day 42

Population: Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.