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

Study Overview
=================
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.

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

Conditions
-----------------
Intensive Care Unit Syndrome

Intervention / Treatment
-----------------
* Device: pharmacokinetic device
* Device: pharmacokinetic device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pharmacokinetic device<br>MON4STRAT system | Device: pharmacokinetic device<br>* MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement<br>Device: pharmacokinetic device<br>* High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | at 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3 days | 
| Minimum concentration of beta-lactams antibiotics | Pharmacokinetic of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | 
| Maximum concentration (CMax) of beta-lactams antibiotics | Pharmacokinetic of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | 
| Clearance (Cl) of beta-lactams antibiotics | Pharmacokinetic of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | 
| Volume of distribution of beta-lactams antibiotics | Pharmacokinetic of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | 
| Half-life (t1/2) of beta-lactams antibiotics | Pharmacokinetic of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | 
| 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. | Antimicrobial doses, serum concentration of β- lactams and minimum inhibitory concentration of microorganisms, if available, will be used to assess the potential usefulness of this bedside method | at 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
device drug monitoring, β-lactam antibiotic, health care-associated infection, MON4STRAT