NCT02917486

Brief Summary

The objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients without Extracorporeal Membrane Oxygenation. The exhibition is evaluated by population pharmacokinetic modeling.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 7, 2016

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

September 5, 2016

Last Update Submit

December 6, 2016

Conditions

Infection

Keywords

ExtraCorporeal Membrane Oxygenationpatient in intensive carepharmacokinetic modeling

Outcome Measures

Primary Outcomes (1)

  • Measure exposure to piperacillin

    evaluated by population pharmacokinetic modeling and is defined by the time during which the antibiotic concentration is greater than 4 times the critical concentration of the germ to treat

    Day 1

Study Arms (2)

ECMO piperacillin

patients in intensive care treated with ECMO with antiinfective therapy : piperacillin

Other: blood sample

without ECMO piperacillin

patients in intensive care without ECMO with antiinfective therapy : piperacillin

Other: blood sample

Interventions

blood sampleOTHER
ECMO piperacillinwithout ECMO piperacillin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in intensive care treated with ECMO or without ECMO

You may qualify if:

  • Age over 18 years
  • Hospitalisation in intensive care
  • Treatment with ECMO or without ECMO
  • Introducing sepsis treated with an anti-infective molecule studied (piperacillin) for less than 48 hours
  • With an arterial catheter
  • Patient Information or their next of kin according to the patients status.

You may not qualify if:

  • Pregnancy
  • Major person under legal protection (backup justice, trusteeship, quardianship), person deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre Fillatre

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Fillatre

CONTACT

pierre.fillatre@chu-rennes.fr

Anne Ganivet

CONTACT

anne.ganivet@chu-rennes.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 28, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

December 7, 2016

Record last verified: 2016-08

Locations

FR(1)