Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted … (NCT03404089) | Clinical Trial Compass
TerminatedNot Applicable
Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.
Stopped: insufficient inclusions
France13 participantsStarted 2018-04-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
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).