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Clinical Trial Details

Trial ID: L1102
Source ID: NCT00882557
Associated Drug: Daptomycin
Title: Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00882557/results
Conditions: End-stage Renal Disease|Renal Failure Chronic Requiring Hemodialysis
Interventions: DRUG: daptomycin|DRUG: daptomycin
Outcome Measures: Primary: Evaluation of Area Under the Curve From Time 0 to Infinity, Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses, Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion) | Secondary: Treatment-emergent Adverse Events, Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests., Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15). | Other: Maximum Plasma Concentration, Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation., Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|Time to Maximum Concentration, Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation., Up to 68 hours post dose|Half-life, Apparent terminal half-life., Up to 68 hours post dose|Clearance of Daptomycin, Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time., Up to 68 hours post dose|Volume of Distribution, Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time., Up to 68 hours post dose
Sponsor/Collaborators: Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-04-29
Completion Date: 2009-07-17
Results First Posted: 2011-10-25
Last Update Posted: 2018-02-06
Locations: West Coast Clinical Trials, Cypress, California, 90630, United States|DaVita Clinical Research, Minneapolis, Minnesota, 55404, United States
URL: https://clinicaltrials.gov/show/NCT00882557