Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of 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: TOC Safety Visit (up to 56 days)

Population: Participants who received any dose of IV study medication.

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

Time frame: Administration of first dose through the last follow-up visit (up to 77 days)

Population: Participants who received any dose of IV study medication

An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.

Time frame: Administration of first dose through the last follow-up visit (up to 77 days)

Population: Participants who received any dose of IV study medication

Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .

Time frame: Baseline up to end of therapy visit (up to 49 days)

Population: Participants who received any dose of IV study medication

Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)

Time frame: Baseline up to end of therapy visit (up to 44 days)

Population: Participants who received any dose of IV study medication

Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.

Time frame: Days 3, 4, 5 or 6 of treatment at end of infusion

Population: Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.

Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.

Time frame: 7-14 days after the last dose of study medication (up to 56 days)

Population: All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.

Time frame: 7-14 days after the last dose of study medication (up to 56 days)

Population: All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.

Time frame: Days 3, 4, 5 or 6 of treatment at pre-dose

Population: Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.