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

NCT03404089 | Terminated DMC

• 3 other identifiers: 2015_782016-A01407-44HEALTH.2013.2.3.1-2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Syndrome

Keywords

device drug monitoring; β-lactam antibiotic; health care-associated infection; MON4STRAT

Outcome Measures

Primary Outcomes (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).

  at 3 days

Secondary Outcomes (7)

• User's questionnaire

  at 3 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

• Volume of distribution of beta-lactams antibiotics

  before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion

Study Arms (1)

pharmacokinetic device

EXPERIMENTAL

MON4STRAT system

Device: pharmacokinetic device

Interventions

pharmacokinetic device DEVICE

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

pharmacokinetic device

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• European Commission: collaborator

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François DUBOS, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: January 19, 2018
• Study Start: April 18, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

FR (1)