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

Stopped early · Phase 4

Conditions studied: Complicated Skin and Skin Structure Infections, S. Aureus Bacteremia, Renal Impairment

In brief

This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance \[CLcr\] 30 - 50 milliliters per minute \[mL/min\] \[moderate impairment\] and \<30 mL/min \[severe impairment\]) and by type of infection (bacteremia and complicated skin and skin structure infections \[cSSSI\]) to create 4 cohorts defined as follows: * Cohort 1: Bacteremia and CLcr \<30 mL/min * Cohort 2: Bacteremia and CLcr 30 - 50 mL/min * Cohort 3: cSSSI and CLcr \<30 mL/min * Cohort 4: cSSSI and CLcr 30 - 50 mL/min Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.

Key facts

Study ID

NCT01104662

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

92

Starts

2010-04-19

Expected to finish

2012-06-12

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Male or female ≥18 years of age
• Diagnosis of cSSSI or Staphylococcus aureus (S. aureus) bacteremia
• Renal impairment of CLcr of 30 - 50 mL/min or CLcr <30 mL/min per Cockcroft-Gault equation using actual body weight
• Functioning hemodialysis access and on stable regimen for those receiving dialysis
• In appropriate health for the study with no acute or chronic illnesses that could adversely impact safety or ability to complete the study
• Specific inclusion criteria for cSSSI:
• Presence of a wound infection, major abscess, severe carbunculosis, infected ulcers, dialysis access site infection, or other type of infection in presence of complicating factor
• At least 3 of the following symptoms, signs, or laboratory values of a skin infection: elevated temperature; elevated white blood cell (WBC) count; pain; tenderness; swelling; erythema greater than 1 centimeter (cm) beyond wound edge; induration; pus formation
• Evidence of a Gram-positive infecting pathogen as indicated by positive Gram stain or culture obtained within 96 hours prior to study drug administration
• Infection of sufficient severity to require parenteral antimicrobial therapy
• Specific inclusion criteria for S. aureus bacteremia:
• Documented S. aureus bacteremia defined as at least one positive blood culture for S. aureus obtained within 96 hours prior to the first dose of study medication

You may not qualify if…

• 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

Where it is running

• Study site — Azusa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Torrance, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Decatur, Georgia, United States
• Study site — Somers Point, New Jersey, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Mission, Texas, United States

Full record on ClinicalTrials.gov

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