Status:
TERMINATED
Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
European Commission
Conditions:
Intensive Care Unit Syndrome
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03404089
Start Date
April 18 2018
End Date
June 30 2019
Last Update
January 19 2023
Active Locations (1)
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1
Hôpital Roger Salengro, CHU
Lille, France