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

Not Applicable

Terminated

• Conditions: Intensive Care Unit Syndrome
• Interventions: Device: pharmacokinetic device

• Registration Number: NCT03404089
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-19
• Study Start: 2018-04-18
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pharmacokinetic device	pharmacokinetic device	MON4STRAT system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
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
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

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France