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Clinical Trial Details

Trial ID: L0881
Source ID: NCT02159859
Associated Drug: Ertapenem
Title: Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02159859/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Ertapenem
Outcome Measures: Primary: Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients, Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session, once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients, Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session, once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients, Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session, once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients, Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session, once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|Mean Time to Cmax of Ertapenem in Hemodialysis Patients, Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session, once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | Secondary: Number of Participants With Diarrhea, Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital, Up to seven days after the administration of ertapenem|Number of Participants With Nausea and Vomiting, Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital, Up to seven days after the administration of ertapenem|Number of Participants With Headache, Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital, Up to seven days after the administration of ertapenem|Number of Participants With Injection Site Reaction, Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital, Up to seven days after the administration of ertapenem | Other: Number of Participants With Any Adverse Events, Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital, Up to seven days after the administration of ertapenem
Sponsor/Collaborators: Sponsor: William Beaumont Hospitals | Collaborators: Wayne State University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 7
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2014-12
Completion Date: 2016-04
Results First Posted: 2017-06-15
Last Update Posted: 2018-10-17
Locations: Oakwood Hospital - Dearborn, Dearborn, Michigan, 48124, United States
URL: https://clinicaltrials.gov/show/NCT02159859