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

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

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.

Study Overview

• Status: Terminated
• Conditions: Intensive Care Unit Syndrome
• Intervention / Treatment: Device: pharmacokinetic device; Device: pharmacokinetic device

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: European Commission
• Investigators: Principal Investigator: François Dubos, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: device drug monitoring; β-lactam antibiotic; health care-associated infection; MON4STRAT
• Other Study ID Numbers: 2015_78; 2016-A01407-44 (Other Identifier: ID-RCB number, ANSM); HEALTH.2013.2.3.1-2 (Other Identifier: FP7-HEALTH-2013-INNOVATION-1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No