Temocillin use in intensive care units:A Pharmacokinetic study of 6g per day in conventional administration vs. continuous infusio

Conditions: Patients will be eligible for participation in the study if they :1.are hospitalized in an intensive care unit2.have an abdominal or a pulmonary infection
MedDRA version: 9.1Level: PTClassification code 10056519Term: Abdominal infection
MedDRA version: 9.1Level: LLTClassification code 10052110Term: Bronchopulmonary infection

Registration Number: EUCTR2007-003223-20-BE

Lead Sponsor: Cliniques Universitaires St Luc - UC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients will be eligible for participation in the study if they :

1.are hospitalized in an intensive care unit
2.have an abdominal or a pulmonary infection

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be eligible to participate in the study if they:

1.are confirmed or suspected infected by a bacteria non-susceptible to Temocillin
2.are allergic to Temocillin or any other penicillin
3.are pregnant women or lactating
4.have participated in an investigational drug study within 4 weeks

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is therefore aimed at determining the pharmacokinetic parameters of temocillin in ICU patients receiving 6g per day by continuous infusion (6g/24h) compared to conventional administration (3×2g). These parameters will be measured in the serum and in different body fluids. In parallel, we will monitor the safety and clinical efficacy of this dosing regimen.;Secondary Objective: ;Primary end point(s): To determin the pharmacokinetic parameters of temocillin in ICU patients receiving 6g per day by continuous infusion (6g/24h) compared to conventional administration (3×2g).

Secondary Outcome Measures