Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

Pregnant or lactating females, or unwilling to practice barrier methods of birth control

Received an investigational drug (including experimental biologic agents) within 30 days of study entry

Unable to discontinue use of HMG-CoA reductase inhibitor therapy while on study

Known allergy or intolerance to daptomycin, penicillin, or vancomycin

Active intravenous (IV) drug abuse

Confirmed or suspected osteomyelitis, septic arthritis, meningitis, epidural abscess, intra-abdominal infection, pneumonia, or infective endocarditis

Required use of non-study systemic antibacterial agent with activity against target pathogen

History of muscular disease

Neurological disease except stroke \>6 months prior to study entry

Intramuscular injection within 7 days of study drug administration

Moribund clinical condition (high likelihood of death during next 3 days)

Shock or hypotension (supine systolic blood pressure \<80 millimeters of mercury \[mmHg\])

Body mass index (BMI) \<18 or \>40 kilograms per meter squared (kg/m\^2) \[BMI = weight (kg)/height (m\^2)\]

Known human immunodeficiency virus (HIV) infection with CD4 count ≤200 cells/millimeter (mm)\^3

Neutropenic participants with an absolute neutrophil count ≤500 cells/mm\^3

Anticipated to develop neutropenia absolute neutrophil count ≤500 due to prior or planned chemotherapy

Alanine aminotransferase (ALT) value \>3 × upper limit of normal (ULN)

Aspartate aminotransferase (AST) value \>3 × ULN

Total bilirubin values ≥ 1.5 x ULN associated with ALT values \>3 x ULN

Creatine phosphokinase (CPK) value \>2 × ULN

Hemoglobin \<8 grams per deciliter (gm/dL)

Unlikely to comply with study procedures or to return for evaluations

History of rhabdomyolysis

Prior enrollment into this study

Infections caused by Gram-positive pathogens known to be resistant to daptomycin or selected comparator agent

Minor or superficial skin infections as the primary site of infection

Cellulitis or erysipelas not associated with complicating factor as primary site of infection

Perirectal abscess, hidradenitis suppurativa, concomitant gangrene, myositis, multiple infected ulcers at distant sites, necrotizing fasciitis, or infected third-degree burn wounds

Infections requiring emergency surgery

Infections suspected or documented to be due exclusively to gram-negative, anaerobic, or fungal organism

Confirmed or suspected disorder that could interfere with the evaluations (for example, primary skin disorders)

Use of a topical antibiotic at the site of the infection

Use of systemic antibacterial therapy for the infection for \>24 hours within 48 hours prior to start of study drug unless (a) infecting Gram-positive pathogen resistant to therapy or (b) therapy administered for 3 or more days with worsening or no improvement

Planned surgical treatment that is considered curative of the infection

Has intravascular foreign material at the time the positive blood culture was drawn (for example., intracardiac pacemaker wires, percutaneous or implanted venous catheters, vascular grafts) unless material removed within 4 days after first dose of study medication or approval of medical monitor (exceptions: vascular stents in place for \>6 months, permanent pacemaker attached via epicardial leads, or any dialysis access device unless this material is felt to be infected)

Prosthetic heart valve

Cardiac decompensation or valve damage or both with high likelihood of valve surgery in the 3 days after randomization

Polymicrobial blood infection

What this study is about