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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intensive Care Unit Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pharmacokinetic device

MON4STRAT system

Group Type EXPERIMENTAL

pharmacokinetic device

Intervention Type DEVICE

MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement

pharmacokinetic device

Intervention Type DEVICE

High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using

Interventions

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pharmacokinetic device

MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement

Intervention Type DEVICE

pharmacokinetic device

High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No