Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03404089
NCT03404089TerminatedNot Applicable

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

University Hospital, Lille1 site in 1 country13 target enrollmentStarted: April 18, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
13
Locations
1
Primary Endpoint
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).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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 Outcomes

  • User's questionnaire(at 3 days)
  • Volume of distribution 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.(at 17 days)
  • Minimum concentration 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(before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion)
  • Clearance (Cl) 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(before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned PatientsAntibioticsSevere BurnIntensive Care
NCT03335137University Hospital Schleswig-Holstein35
Not yet recruiting
Not Applicable
Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA PatientsPost-cardiac SurgeryExtracorporeal Membrane Oxygenation ComplicationInfectionsCardiac ArrestCardiogenic Shock
NCT06338345University Hospital, Grenoble225
Completed
Not Applicable
Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption SpectroscopyInfection, BacterialSepsis
NCT04282785Uppsala University36
Completed
Not Applicable
The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit PatientsSepsis
NCT02446392Linkoeping University120
Unknown
Not Applicable
Beta-lactam Therapeutic Drug Monitoring in SingaporeInfection, Bacterial
NCT04450680Singapore General Hospital80