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| Name | Class |
|---|---|
| Wayne State University | OTHER |
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The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.
After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertapenem | Experimental | Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertapenem | Drug | Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lama Hsaiky, Pharm.D. | Oakwood Hospital - Dearborn | Principal Investigator |
| Lama Hsaiky, Pharm.D. | Oakwood Hospital - Dearborn | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakwood Hospital - Dearborn | Dearborn | Michigan | 48124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29992286 | Result | Hsaiky LM, Salinitri FD, Wong J, Jennings ST, Desai NH, Lobkovich AM, Cha R. Pharmacokinetics and investigation of optimal dose ertapenem in intermittent hemodialysis patients. Nephrol Dial Transplant. 2019 Oct 1;34(10):1766-1772. doi: 10.1093/ndt/gfy166. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ertapenem | Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session Ertapenem: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ertapenem | Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mcg/ml | 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 |
|
within 7days post enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ertapenem | Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Endocrine disorders | Systematic Assessment |
some participants had missing lab values at the pre-determined times
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lama Hsaiky, Pharm.D. (Primary investigator) | Beaumont Health | 313-593-7264 | lama.hsaiky@beaumont.org |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| 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 |
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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kilograms |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | mcg/ml | 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 |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | h*ug/mL | 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 |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | hours | 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 |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | hours | 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 | Posted | Count of Participants | Participants | Up to seven days after the administration of ertapenem |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to seven days after the administration of ertapenem |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to seven days after the administration of ertapenem |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to seven days after the administration of ertapenem |
|
|
|
| Other Pre-specified | 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 | Posted | Count of Participants | Participants | Up to seven days after the administration of ertapenem |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| hypertension | Vascular disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Muscle jerking | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rusty urine | Renal and urinary disorders | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |