Daptomycin Study - Collection of Pharmacokinetic Samples... | NCT00573898

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

NCT00573898

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Feb 18, 2011Estimated

Enrollment

5Estimated

Phase

Not provided

Conditions

Renal Failure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Not provided

Completion Date

Dec 2010Actual

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 13, 2007

First Posted Date

Dec 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2011

Last Update Posted Date

Feb 18, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients receiving daptomycin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather Johnson, Pharm D	University of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.