Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.

University Hospital, Lille13 enrolled

Overview

This study evaluate the capacity of the MON4STRAT device for drug monitoring of β- lactam antibiotic concentrations in newborns, children, and adolescents admitted in intensive care units with a health care-associated infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Intensive Care Unit Syndrome

Interventions

pharmacokinetic deviceDEVICE

MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement

pharmacokinetic deviceDEVICE

High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age younger than 18 years * Newborns (preterm or not) in neonatal intensive care * Infants, children, and adolescents in pediatric intensive care * Clinically suspected or microbiologically proven sepsis that might be associated with ventilator-associated pneumonia or otherwise associated with health care * Need for antibiotic treatment by piperacillin-tazobactam, ceftazidime, or meropenem of intermittent administration * Informed consent form signed by parents/guardian * Informed consent form signed by patients old enough to understand. Exclusion Criteria: * Process for active limitation of treatment underway * Suspected or known hypersensitivity to studied beta-lactams * Renal failure, defined as serum creatinine \> 1.5 mg/dl or urine production \< 0.3 ml/kg for 24 h or anuria for 12 h. * Co-administration of two β-lactam antibiotics * Cystic fibrosis * No national health insurance coverage in French center * Family unable to understand study-related information due to language or other communication issues * No consent obtained

Locations (1)

Hôpital Roger Salengro, CHU

Lille, France

Outcomes

Primary Outcomes

Correlation between the β-lactam dosage measured by the MON4STRAT method and the β-lactam dosage measured by the HPLC-MS-MS (the reference method).

Time frame: at 3 days

Secondary Outcomes

User's questionnaire

The feasibility of the MON4STRAT method will be evaluated by a questionnaire to be completed by the users of the method, that is, the nurses caring for these patients.

Time frame: at 3 days

Minimum concentration of beta-lactams antibiotics