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

U

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

pharmacokinetic device
Experimental group
Description:
MON4STRAT system
Treatment:
Device: pharmacokinetic device
Device: pharmacokinetic device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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