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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00177931
Other study ID # IRB # 0403014
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated December 16, 2015
Start date March 2005
Est. completion date December 2009

Study information

Verified date December 2015
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purposes of this study are to:

I. Characterize the plasma concentration-time profile of cefepime in liver transplant patients to determine the pharmacokinetic parameters in this patient population.

II. Perform stochastic modeling using the population pharmacokinetic parameters obtained in Specific Aim I to determine the ideal dose and dosing regimen of cefepime required to attain predetermined therapeutic targets in liver transplant patients.


Description:

The use of cefepime in liver transplant patients at conventional doses used for other patient populations leads to non-optimal drug exposure among liver transplant patients. Furthermore, using serum creatinine as a method of estimating creatinine clearance is not the optimal way to determine the best cefepime dose. The consequence of this non-optimal exposure is the unattainability of therapeutic targets. These therapeutic targets are correlated with positive microbiologic outcome and clinical cure.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women and members of minority groups will be included in this study. However, as this study seeks to generate pilot data, there will be no specific statistical analysis comparing differences based on gender or race.

- Subjects receiving drugs known to induce or inhibit hepatic enzymes are not excluded from this study as cefepime is renally eliminated and not significantly metabolized by the liver.

- All liver transplant subjects are eligible for enrollment in this study, including subjects who have undergone a living related liver transplant.

- The pharmacokinetics of cefepime in children are significantly different from those of adults. For the purposes of this study only adults (aged > 18 years old) will be able to participate.

Exclusion Criteria:

- Subjects will be excluded if they are anemic (hemoglobin < 7 mg/dl), or are patients with severe gastrointestinal bleeding who are receiving packed red blood cells.

- Subjects who are receiving hemodialysis or other forms of renal replacement therapy (such as continuous veno-venous hemofiltration), or patients with a calculated creatinine clearance of < 10 ml/min will be excluded from the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Evidence of Liver Transplantation

Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary dead or alive post treatment December 2009 No
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