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

Intensive Care Unit Syndrome Clinical Trial

— MON4STRAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03404089
• Other study ID #: 2015_78
• Secondary ID: 2016-A01407-44HE
• Status: Terminated
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Intervention

Device:
• pharmacokinetic device
MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement
• pharmacokinetic device
High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	European Commission

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the ß-lactam dosage measured by the MON4STRAT method and the ß-lactam dosage measured by the HPLC-MS-MS (the reference method).		at 3 days
Secondary	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
Secondary	Minimum concentration of beta-lactams antibiotics	Pharmacokinetic of beta-lactams antibiotics	before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Secondary	Maximum concentration (CMax) of beta-lactams antibiotics	Pharmacokinetic of beta-lactams antibiotics	before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Secondary	Clearance (Cl) of beta-lactams antibiotics	Pharmacokinetic of beta-lactams antibiotics	before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Secondary	Volume of distribution of beta-lactams antibiotics	Pharmacokinetic of beta-lactams antibiotics	before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Secondary	Half-life (t1/2) of beta-lactams antibiotics	Pharmacokinetic of beta-lactams antibiotics	before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Secondary	Assessment of the course of infection of children who had a ß-lactam assay (by the reference method) at the usual levels and those who appeared to receiving inadequate ß-lactam doses.	Antimicrobial doses, serum concentration of ß- lactams and minimum inhibitory concentration of microorganisms, if available, will be used to assess the potential usefulness of this bedside method	at 17 days