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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02917486
Other study ID # 35RC15_8901
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2016
Last updated December 6, 2016
Start date January 2016
Est. completion date July 2019

Study information

Verified date August 2016
Source Rennes University Hospital
Contact Pierre Fillatre
Email pierre.fillatre@chu-rennes.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Pregnancy

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
blood sample


Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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