Neonatal late onset sepsis MedDRA version: 20.1 Level: LLT Classification code 10053598 Term: Late onset neonatal sepsis System Organ Class: 100000004862
Conditions
Sponsors
Erasmus University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Neonates with gestational age 500 pg/ml or if CRP > 50 mg/L Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - PTX therapy cannot be started within 24 hours of start of antibiotic treatment. - Patients with major congenital defects (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies) will also be excluded. - If subjects have IL-6 values exceeding 25000 pg/mL at time of onset they will also be excluded. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates. - Patients who already participated in this trial during an earlier episode of late onset sepsis. - Patients with pH below 7 in two consecutive blood samples, with at least 1 hour between the blood samples, at start of sepsis episode.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to determine in what optimal dose PTX should be used in preterm infants suffering from sepsis. Previous clinical studies have already indicated the safety of the drug in preterm infants. ;Secondary Objective: - To further understand the inflammatory and immunological changes of preterm infants during sepsis with PTX treatment. We will longitudinally evaluate 91 inflammatory markers (Olink proteomics) and metabolomics of the whole inflammatory panel, . - To study the pharmacokinetics of PTX and its metabolites in preterm infants - To calculate a target concentration for PTX and its metabolites and develop a PK/PD model ;Primary end point(s): Dose optimisation will be based on the clinical and biochemical (CRP, IL-6, PCT, TNF-a) effects and on adverse drug effects.;Timepoint(s) of evaluation of this end point: 3 days after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include the evaluation of longitudinally determined 91 inflammatory markers (Olink proteomics) and metabolomics of the whole inflammatory panel. Furthermore a target concentration of PTX and its metabolites will be calculated and PK/PD model for PTX will be developed. ;Timepoint(s) of evaluation of this end point: During sepsis episode. | — |
Countries
Netherlands, Poland
Contacts
Public ContactNeonatology Division head
Erasmus University medical Center
Outcome results
None listed