PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

Inclusion Criteria:

- Written parental (or appropriate legal representative) informed consent prior to any
study-related procedure not part of normal medical care;

- Male or female between the ages of 2 and 6 years old, inclusive;

- Able to comply with the protocol for the duration of the study;

- Clinically stable with no evidence of hemodynamic instability (defined as a
requirement for pharmacological intervention to manage blood pressure) in the 72 hour
window prior to enrollment, and no history or evidence of renal or hepatic compromise;

- Suspected or diagnosed Gram-positive infection for which the subject is receiving
standard antibiotic therapy;

- A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the
Schwartz equation at baseline;

- Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at
baseline.

- Presence of two patent intravenous lines (or comparable means of venous access) prior
to dosing on Study Day 1.

Exclusion Criteria:

- Investigational drug use (including daptomycin) or participation in any experimental
procedure in the 30 days preceding study entry;

- Known allergy/ hypersensitivity to daptomycin;

- History of clinically significant cardiovascular, renal, hepatic, pulmonary
(well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic,
autoimmune disease or primary immune deficiency;

- Pneumonia as sole Gram-positive infection being treated with standard antibiotics;

- Subjects with clinically significant abnormal laboratory test results [including
electrocardiograms (ECGs)], as determined by Investigator;

- Administration of rifampin within 7 days of study drug administration;

- Body mass index (BMI) that is outside of the 5th to 95th percentile;

- Subjects in whom collection of the required blood volume would put them at risk of
hemodynamic disturbance (at the discretion of Investigator);

- History of or current clinically significant (at the discretion of the Investigator)
muscular disease, nervous system or seizure disorder;

- Administration of intramuscular injection between baseline and study drug
administration or expected intramuscular injection within 24 hours following dosing;

- Expected surgical procedure(s) within 24 hours prior to and following dosing;

- Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or
spinal cord injury;

- History of or current rhabdomyolysis.