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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
Unnamed facility
Azusa, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Decatur, Georgia, United States
Unnamed facility
Somers Point, New Jersey, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
West Reading, Pennsylvania, United States
Unnamed facility
Mission, Texas, United States
Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)
The number of participants with CPK elevations of \>500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.
Time frame: Baseline through EOT/ET
Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit
Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit: Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection \>4 days after starting study medication. Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit. Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received \<4 days of study medication or were not assessed by the Investigator.
Time frame: Baseline through TOC/Safety Visit
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