Pharmacokinetics of Piperacillin/Tazobactam in Patients Treated by Continuous Renal Replacement Therapy - Full Text View

Sponsored by:	University Hospital, Toulouse
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00703144

Purpose

The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.

Condition	Intervention	Phase
Diffusive and Convective Clearance Body Clearance Piperacillin Tazocilline Concentrations (Cmin)	Drug: piperacillin/tazobactam	Phase IV

Drug Information available for: Piperacillin Piperacillin sodium Tazobactam Zosyn

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body clearance [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days

Detailed Description:

The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. This is a prospective study.

Continuous replacement therapy has a continuous effect on drug elimination which could compromise effective antibiotic treatment.

Patients will receive a standard course of pip/tazo 4g intravenously 8 hourly administrated immediately when CVVHDF will be started.

Blood samples will be collected at 30mn, 2h, 4h, 6h, 8h, 16h, 24h for the first and the second day.

We will measure plasma piperacillin/tazobactam concentration and compare them to MICs for the whole dosing interval.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age and older .
Females of childbearing potential must have a negative pregnancy test at screening.
Subjects whose life expectancy is estimated over 7 days.
Anuric patients requiring continuous venovenous hemodiafiltration
Septic patients,severe sepsis or septic shock
Written informed consent should be given either by the patient or a member of his family

Exclusion Criteria:

Subjects with a history of true allergy or adverse drug reactions
Pathogens whose antibiotic susceptibility is not proved.
Patients having impaired hepatic function
Contraindication of anticoagulation by heparin
Residual renal function
Participation in a clinical trial
Interruption of treatment by piper/tazo or hemodiafiltration during the study.
Patients with psychiatric disorder or serious medical condition which in the opinion of the investigator may lead to complexity in patient management.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703144

Contacts

Contact: LAVAYSSIERE Laurence, MD

33-561322671

lavayssiere.l@chu-toulouse.fr

Locations

France
Service de Néphrologie	Recruiting
Toulouse, France, 31059
Contact: LAVAYSSIERE Laurence
Contact: NOGUIER Marie-Beatrice
Principal Investigator: LAVAYSSIERE Laurence
Sub-Investigator: NOGUIER Marie-Beatrice, MD
Sub-Investigator: CONIL Jean-Marie, MD
Sub-Investigator: COINTAULT Olivier, MD

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator:

LAVAYSSIERE Laurence, MD

University Hospital, Toulouse

More Information

Responsible Party:	University Hospital Toulouse ( LLAU Marie-Elise )
Study ID Numbers:	07 300 02, University Hospital Toulouse
Study First Received:	June 20, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00703144
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Toulouse:

Pharmacokinetics
piperacillin/tazobactam.
Septic patients
oliguric renal failure undergoing continuous veno-venous hemodiafiltration.

Study placed in the following topic categories:

Penicillanic Acid
Tazobactam
Piperacillin
Piperacillin-tazobactam combination product
Kidney Failure

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009