infection
Conditions
Interventions
modeling group:newborns/young infants(50/20)
validation group:newborns/young infants(15/5)
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age <61 days; 2. sufficient intravascular access (either peripheral or central) to receive study drug; 3. suspected or confirmed bacterial infection, receiving piperacillin/tazobactam or vancomycin as part of standard of care following clinical decision by attending physician.
Exclusion criteria
Exclusion criteria: 1. severely ill that they were not likely to survive the duration of the trial (at least 8 days); 2. hepatic dysfunction evidenced by AST or ALT >=90% for corrected postmenstrual age (PMA); 3. renal dysfunction evidenced by serum creatinine (SCR) >=90% for infants postmenstrual age =(mean + 3 standard deviations) for other gestational ages; 4. having received a systemic investigational drug; 5. having any condition which in the opinion of the investigator made the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| detection of drug concentration; | — |
Countries
China
Contacts
Public ContactZhiping Li
Outcome results
None listed