Daptomycin Study - Collection of Pharmacokinetic Samples in Patients With Renal Failure
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Purpose
This will be a prospective, multicenter, open-labeled, non-comparative pharmacokinetic study conducted in 10 critically ill, anuric patients receiving CVVHDF. Enrollment will take place at 3-5 clinical sites in the United States. A study coordinator at each site will be identified and institutional specific processes (e.g., pharmacy records, etc.) will be utilized to identify patients. Full evaluation of inclusion and exclusion criteria will be conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy. Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a suspected/documented infection, as deemed necessary by the treating clinician will be screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate utilized during the CVVHDF procedure will be determined by clinicians at discretion to optimize stability of patients.
Daptomycin samples will be obtained around the third dose in an attempt to achieve approximate steady-state concentrations. Pre- and post-filter blood samples will be collected simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein binding will be assessed by filtration of the serum samples at the peak drug concentration time points.
| Condition |
|---|
|
Renal Failure |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Pharmacokinetics of Daptomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) |
- The primary objective of this study will be to determine the pharmacokinetic parameters of daptomycin 6mg/kg once daily in patients receiving CVVHDF, and the rate of drug clearance through the renal replacement apparatus. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
All of your biologic samples will be under the control of the principal investigator of this research project. To protect your confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. You may request to have your samples destroyed if you withdraw. The request must be in writing and samples collected and not already processed will be destroyed.
| Estimated Enrollment: | 5 |
| Study Start Date: | March 2008 |
| Study Completion Date: | December 2010 |
Enrollment will take place at 3-5 clinical sites in the United States. Full evaluation of inclusion and exclusion criteria will be conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy. Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a suspected/documented infection, as deemed necessary by the treating clinician will be screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate utilized during the CVVHDF procedure will be determined by clinicians at discretion to optimize stability of patients.
Daptomycin samples will be obtained around the third dose in an attempt to achieve approximate steady-state concentrations. Pre- and post-filter blood samples will be collected simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein binding will be assessed by filtration of the serum samples at the peak drug concentration time points.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients receiving daptomycin
Inclusion Criteria:
- This study will be conducted in adult critically ill patients receiving CVVHDF who are prescribed daptomycin 6mg/kg once daily as part of required medical care for suspected/documented infection, as deemed necessary by his or her treating clinician.
Exclusion Criteria:
Daptomycin therapy will be chosen by the treating physician based on clinical indication and it is expected that risks of therapy will have already been considered; therefore, subjects are only to be excluded based on covariates that are expected to affect pharmacokinetics. Subjects will be excluded if they are:
- less than 18 years of age
- producing urine greater than 50 ml per 24 hours
- have a life expectancy less than 96 hours
- receiving CVVHDF utilizing rates or filters that are NOT otherwise considered "standard" by the enrolling site
- receive less than 3 doses of daptomycin
- participating in any other study
Contacts and Locations| United States, Pennsylvania | |
| UPMC | |
| PIttsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Heather Johnson, Pharm D | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Heather Johnson, Pharm D, UPMC |
| ClinicalTrials.gov Identifier: | NCT00573898 History of Changes |
| Other Study ID Numbers: | PRO07060252 |
| Study First Received: | December 12, 2007 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
daptomycin |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases Daptomycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013