NCT00703144

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

4.2 years

First QC Date

June 20, 2008

Last Update Submit

January 23, 2013

Conditions

Diffusive and Convective ClearanceBody ClearancePiperacillin Tazocilline Concentrations (Cmin)

Keywords

Pharmacokineticspiperacillin/tazobactam.Septic patientsoliguric renal failurecontinuous veno-venous hemodiafiltration.

Outcome Measures

Primary Outcomes (1)

  • Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus

    2 days

Secondary Outcomes (1)

  • Body clearance

    2 days

Study Arms (1)

Pharmacokinetic

EXPERIMENTAL
Drug: piperacillin/tazobactamProcedure: Pharmacokinetic

Interventions

piperacillin/tazobactamDRUG

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

Also known as: Tazocilline
Pharmacokinetic
PharmacokineticPROCEDURE
Pharmacokinetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Néphrologie

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Piperacillin, Tazobactam Drug CombinationPharmacogenomic Variants

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsPolymorphism, GeneticGenetic VariationGenetic Phenomena

Study Officials

  • LAVAYSSIERE Laurence, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

FR(1)