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

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.