Intensive Care Unit Syndrome
Conditions
Keywords
device drug monitoring, β-lactam antibiotic, health care-associated infection, MON4STRAT
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.
Interventions
DEVICEpharmacokinetic device
MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement
Sponsors
European Commission
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Minimum concentration of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | Pharmacokinetic of beta-lactams antibiotics |
| Maximum concentration (CMax) of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | Pharmacokinetic of beta-lactams antibiotics |
| Clearance (Cl) of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | Pharmacokinetic of beta-lactams antibiotics |
| User's questionnaire | at 3 days | 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. |
| Half-life (t1/2) of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | Pharmacokinetic of beta-lactams antibiotics |
| 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. | at 17 days | 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 |
| Volume of distribution of beta-lactams antibiotics | before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion | Pharmacokinetic of beta-lactams antibiotics |
Countries
France
Outcome results
None listed