Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care. (MON4STRAT)

University Hospital, Lille

Status

Terminated

Conditions

Intensive Care Unit Syndrome

Treatments

Device: pharmacokinetic device

Study type

Interventional

Funder types

Other

Identifiers

NCT03404089

2016-A01407-44 (Other Identifier)

HEALTH.2013.2.3.1-2 (Other Identifier)

2015_78

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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