Bedside Therapeutic Monitoring of β-Lactam Levels in Newb... | NCT03404089

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

NCT03404089

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

Jan 19, 2023Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Intensive Care Unit Syndrome

Interventions

pharmacokinetic device
pharmacokinetic device

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-A01407-44	Other Identifier	ID-RCB number, ANSM
HEALTH.2013.2.3.1-2	Other Identifier	FP7-HEALTH-2013-INNOVATION-1

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient inclusions

Expanded Access Info

Start Date

Apr 18, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Nov 28, 2017

First Submission Date that Met QC Criteria

Jan 18, 2018

First Posted Date

Jan 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2023

Last Update Posted Date

Jan 19, 2023Actual

Name	Class
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pharmacokinetic device	Experimental	MON4STRAT system	Device: pharmacokinetic device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pharmacokinetic device	Device	MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement	pharmacokinetic device

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
François DUBOS, MD,PhD	University Hospital, Lille	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D003428	Cross Infection

Ancestor Terms

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided