Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

Inclusion Criteria:

1. Written parental (or appropriate legal representative) informed consent prior to any
study-related procedure not part of normal medical care; 2.1 Male or female between the
ages of 3 months and 24 months, inclusive; 3. Able to comply with the protocol for the
duration of the study; 4.1 Clinically stable with no evidence of hemodynamic instability
(defined as a requirement for inotropic or vasodilatory support to manage blood pressure)
in the 24 hour window prior to first dose, and no history or evidence of renal or hepatic
compromise; 5.1 Suspected or diagnosed bacterial infection for which the subject is
receiving standard antibiotic therapy; including prophylactic use of antibiotics
peri-operatively; 6. A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as
determined by the Schwartz equation at baseline; 7. Creatine phosphokinase (CPK) levels
less than 2X ULN (upper limit of normal) at baseline; 8.1 Presence of two patent
intravenous lines (or comparable means of venous or arterial access)prior to dosing on
Study Day 1. A single intravenous line (or comparable means of venous access) is acceptable
for both drug administration and sample collection if reasonable effort to gain a second
line is unsuccessful. The line must be flushed as described in Appendix B of the protocol
prior to obtaining PK samples. PK sample can be obtained from a peri-operatively placed
arterial line. Arterial PK samples should be indicated on the CRF.

Exclusion Criteria:

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

2. Known allergy/ hypersensitivity to daptomycin; 3.1 History of clinically significant,
renal, hepatic, autoimmune disease or primary immune deficiency;

4. Deleted 5. Subjects with clinically significant abnormal laboratory test results
(including ECGs), as determined by Investigator; 6. Administration of rifampin within 7
days of study drug administration; 7. Deleted 8. Subjects in whom collection of the
required blood volume would put them at risk of hemodynamic disturbance (at the discretion
of Investigator); 9. Deleted; 10.1 Planned administration of intramuscular injection within
12 hours following study administration unless approved by the Medical Monitor; 11. Deleted
12.1 Guillian-Barre or spinal cord injury; 13. History of or current rhabdomyolysis.