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

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ClinicalTrials.gov Identifier: NCT03404089
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intensive Care Unit Syndrome Device: pharmacokinetic device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: at 3 days ]

Secondary Outcome Measures :
  1. User's questionnaire [ Time Frame: 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.

  2. Minimum concentration of beta-lactams antibiotics [ Time Frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion ]
    Pharmacokinetic of beta-lactams antibiotics

  3. Maximum concentration (CMax) of beta-lactams antibiotics [ Time Frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion ]
    Pharmacokinetic of beta-lactams antibiotics

  4. Clearance (Cl) of beta-lactams antibiotics [ Time Frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion ]
    Pharmacokinetic of beta-lactams antibiotics

  5. Volume of distribution of beta-lactams antibiotics [ Time Frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion ]
    Pharmacokinetic of beta-lactams antibiotics

  6. Half-life (t1/2) of beta-lactams antibiotics [ Time Frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion ]
    Pharmacokinetic of beta-lactams antibiotics

  7. 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. [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404089


Contacts
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Contact: François DUBOS, MD,PhD 3 20 44 46 64 ext +33 francois.dubos@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: françois DUBOS, MD         
Sponsors and Collaborators
University Hospital, Lille
European Commission
Investigators
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Principal Investigator: François DUBOS, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03404089    
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 )
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
device drug monitoring
β-lactam antibiotic
health care-associated infection
MON4STRAT