Clinical trial NCT03404089: Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.
Official title: Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Keywords: device drug monitoring
β-lactam antibiotic
health care-associated infection
MON4STRAT
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2018-01-19
Enrollment: 13
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: at 3 days
Secondary outcomes:
measure: User's questionnaire
timeFrame: at 3 days
measure: Minimum concentration of beta-lactams antibiotics
timeFrame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
measure: Maximum concentration (CMax) of beta-lactams antibiotics
timeFrame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
measure: Clearance (Cl) of beta-lactams antibiotics
timeFrame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
measure: Volume of distribution of beta-lactams antibiotics
timeFrame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
measure: Half-life (t1/2) of beta-lactams antibiotics
timeFrame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
measure: Assessment of the course of infection of children who had a β-lactam assay (by the reference method) at the usual levels and those who appeared to receiving inadequate β-lactam doses.
timeFrame: at 17 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: François DUBOS, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: