Population Pharmacokinetics and Pharmacodynamics of Beta-lactams of Interest in Adult Patients From Intensive Care Units

Summary

Antibiotics are still most often administered on an empiric fashion, as defined for the general population with dosages only adapted based on weight and renal and/or hepatic functions. As a result, serum concentrations show important interpatient variations with the risk of being subtherapeutic or toxic. Recent studies with temocillin, ceftriaxone, or meropenem confirm this for patients in intensive care units.

The aim of the study will be to measure the total and free concentrations of temocillin, ceftriaxone, and meropenem in patients hospitalized in Intensive Care Units for pulmonary infections or another infection for which one of the above mentioned antibiotics is indicated. Patients will be stratified according to the level of their renal function. The antibiotics will be assayed in plasma as well as other accessible fluids in order to assess their pharmacokinetic properties.

Conditions

• Pharmacokinetics
• Anti-Bacterial Agents
• Infection, Bacterial
• Infections, Respiratory
• Infection
• Drug Monitoring

Interventions

DRUG

blood sampling

* temocillin: blood sampling every day for 7 days * ceftriaxone: blood sampling 12h after administration for 7 days * meropenem: blood sampling at 1h, 3h, 5h and 8h after initiation of the administration at days 1 and 2; one sampling at 8h on days 3 to 7

DRUG

Tissue sampling (lung)

Sampling of tissue (lung) when possible during treatment for measurement of the content in antibiotic (temocillin, ceftriaxone, or meropenem, depending on the drug received by the patient)

DRUG

Collection of fluid samples

Collection of fluid samples (bronchoalveolar lavage, drainage fluid) for determination of antibiotic ((temocillin, ceftriaxone, or meropenem, depending on the drug received by the patient) concentration when possible during treatment

Sponsors & Collaborators

• Université Catholique de Louvain

  lead OTHER

Principal Investigators

• Pierre-François Laterre, MD · Université Catholique de Louvain

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-15

Primary Completion

2022-10-15

Completion

2022-12-15

Countries

• Belgium

Study Locations