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Pharmacokinetics Ertapenem Burns

Primary Purpose

Burn Patients

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Ertapenem

About this trial

This is an interventional treatment trial for Burn Patients focused on measuring Burns, Ertapenem, Pharmacokinetics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ertapenem

Arm Description

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

Outcomes

Primary Outcome Measures

Measurement of serum concentrations of total ertapenem from the second injection in order to calculate Cmax, Vz, ClP , ClR , ClNR , fe, T1/2b et AUC0 - alpha.

Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients.

Secondary Outcome Measures

Time between injection and observation of a serum concentration less than the critical concentration below

Check that the injection of 1 g ertapenem achieves a serum concentration above the critical concentration of bacteria usually isolated in cases of early infection for more than 40% of the time between two injections (t / MIC> 40 %), this ratio being one of the criteria predictive of efficacy of beta-lactam antibiotics.

Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections

Study when two injections of ertapenem serum concentrations fall below the critical concentrations of bacteria usually isolated in cases of early infection, if they become.

Full Information

NCT ID

NCT01497990

First Posted

December 15, 2011

Last Updated

November 2, 2012

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01497990

Brief Title

Pharmacokinetics Ertapenem Burns

Official Title

Pharmacokinetics of Ertapenem When Used in Empiric Treatment in Burn Patients. Prospective Open Label Study.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Patients

Keywords

Burns, Ertapenem, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ertapenem

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Ertapenem

Intervention Description

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

Primary Outcome Measure Information:

Title

Measurement of serum concentrations of total ertapenem from the second injection in order to calculate Cmax, Vz, ClP , ClR , ClNR , fe, T1/2b et AUC0 - alpha.

Description

Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients.

Time Frame

Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection

Secondary Outcome Measure Information:

Title

Time between injection and observation of a serum concentration less than the critical concentration below

Description

Time Frame

Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection

Title

Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections

Description

Study when two injections of ertapenem serum concentrations fall below the critical concentrations of bacteria usually isolated in cases of early infection, if they become.

Time Frame

Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronan LE FLOCH, PH

Organizational Affiliation

Nantes University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Nantes University Hospital

City

Nantes

ZIP/Postal Code

44000

Country

France

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics Ertapenem Burns

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