Daptomycin Study - Collection of Pharmacokinetic Samples in Patients With Renal Failure

NCT00573898 | Completed DMC

• 1 other identifier: PRO07060252
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure

Keywords

daptomycin

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients receiving daptomycin

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Heather Johnson, Pharm D

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: March 1, 2008
• Study Completion: December 1, 2010
• Last Updated: February 18, 2011

Record last verified: 2011-02

Locations

US (1)