Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
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Purpose
The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Continuous Ambulatory Peritoneal Dialysis End Stage Renal Disease |
Drug: ertapenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis |
- Volume of Distribution, Central Compartment (Vc) [ Time Frame: 12h ] [ Designated as safety issue: No ]Population PK
- Clearance (CL) [ Time Frame: 12h ] [ Designated as safety issue: No ]population PK clearance
- k12 [ Time Frame: 12h ] [ Designated as safety issue: No ]1st order intercompartmental rate constant between central and peripheral compartments
- k21 [ Time Frame: 12h ] [ Designated as safety issue: No ]1st order intercompartmental rate constant from peripheral to central compartment
- k13 [ Time Frame: 12h ] [ Designated as safety issue: No ]1st order intercompartmental rate constant from central to peritoneal cavity
- k31 [ Time Frame: 12h ] [ Designated as safety issue: No ]1st order intercompartmental rate constant peritoneal cavity to central
- Residual Drug in Peritoneal Cavity After 1st Exchange [ Time Frame: 6h ] [ Designated as safety issue: No ]
| Enrollment: | 7 |
| Study Start Date: | June 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ertapenem 500 mg IV x1
All patients will receive ertapenem 500 mg IV once.
|
Drug: ertapenem
500 mg IV once
Other Name: Invanz
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
i. Inclusion criteria Adult patients (≥ 18 years), non-infected (afebrile, lack of constitutional symptoms and no leukocytosis), on a stable PD regimen (at least one month) are eligible for participation. Both patients with and without residual renal function will be studied. Non-anuric patients concurrently receiving medications with the potential to inhibit active tubular secretion will be allowed to enter the study after a 2-week washout period. These medications include H2-antagonists, trimethoprim, or probenecid. The patient and their physician at the Hortense and Louis Rubin Dialysis Center will contacted if any medication needs to be discontinued.
ii. Exclusion criteria Patients will be ineligible for the study if they have had peritonitis within the previous 4 weeks, clinical signs or symptoms of active infection, elevated white blood cell count, or treatment with any antibiotic within the previous 2 weeks. Patients with a hemoglobin (hgb) < 11 g/dL will be ineligible for study inclusion. Patients with stated or documented allergies to beta-lactams medications will not be eligible. Pregnant or breastfeeding women will not be eligible for inclusion. All women of child-bearing age will need to yield a serum hCG ≤ 5 mIU/mL within 2 weeks of the scheduled study day. Patients taking valproic acid will also be excluded.
Contacts and Locations| United States, New York | |
| Hortense and Louis Rubin Dialysis Center | |
| Clifton Park, New York, United States, 12065 | |
| Principal Investigator: | Katie E Cardone, PharmD | Albany College of Pharmacy and Health Sciences |
More Information
No publications provided
| Responsible Party: | Katie Cardone, Assistant Professor, Albany College of Pharmacy and Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00939952 History of Changes |
| Other Study ID Numbers: | 35922, 09-006 |
| Study First Received: | July 14, 2009 |
| Results First Received: | July 25, 2012 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Albany College of Pharmacy and Health Sciences:
|
ertapenem CAPD dialysis |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Ertapenem Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013