Pharmacokinetics Ertapenem Burns

NCT ID: NCT01497990

Last Updated: 2012-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

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This study will examine the pharmacokinetics of ertapenem in ventilated badly (\> 30% SCT) burn patients.

Detailed Description

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Conditions

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Burn Patients

Keywords

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Burns Ertapenem Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ertapenem

The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.

Interventions

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Ertapenem

The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 to 70 years
* Burned on 30 to 60% of their body surface
* Mechanical ventilation
* Hospitalized in the intensive care unit of Nantes University Hospital for less than 8 days.
* Which the family gave consent
* insured

Exclusion Criteria

* Patients whose family refused to sign the consent for participation.
* Patients allergic to beta lactam
* Patients with renal failure with creatinine clearance \<80 ml.mn-1
* Pregnant women
* Persons protected by the law
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronan LE FLOCH, PH

Role: STUDY_CHAIR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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09/3-W

Identifier Type: -

Identifier Source: org_study_id