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Clinical Trial Details

Trial ID: L0672
Source ID: NCT01012089
Associated Drug: Daptomycin
Title: Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01012089/results
Conditions: Chronic Kidney Disease|Bacterial Infection
Interventions: DRUG: Daptomycin
Outcome Measures: Primary: Maximum Plasma Concentration (Cmax), 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose|Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24), 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose|Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48), 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞), 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|Volume of Distribution at Steady State (Vss), The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug, 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|Elimination Rate Constant (Ke), 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|Total Drug Clearance (CLtotal), The rate at which a drug substance is removed from the body, 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|Drug Clearance Due to Dialysis (CLdialysis), The rate at which a drug substance is removed from the body due to dialysis therapy, 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose |
Sponsor/Collaborators: Sponsor: University of Oklahoma | Collaborators: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Gender: ALL
Age: CHILD
Phases:
Enrollment: 6
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2009-11
Completion Date: 2014-04
Results First Posted: 2018-06-06
Last Update Posted: 2018-06-06
Locations: The Children's Hospital at the University of Oklahoma Medical Center, Oklahoma City, Oklahoma, 73013, United States
URL: https://clinicaltrials.gov/show/NCT01012089