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

Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.

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.

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