Pharmacokinetics Ertapenem Burns

NCT01497990 | Completed Phase 4 DMC

• 1 other identifier: 09/3-W
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burn Patients

Keywords

Burns; Ertapenem; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

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

  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

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

  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

Study Arms (1)

Ertapenem

EXPERIMENTAL

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

Drug: Ertapenem

Interventions

Ertapenem 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.

Ertapenem

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Burns

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronan LE FLOCH, PH

  Nantes University Hospital

  STUDY CHAIR

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: December 15, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 5, 2012

Record last verified: 2012-11

Locations

FR (1)