Pentoxifylline dose optimization in preterm neonatal sepsis
- Conditions
- bloodstream infectionlate onset sepsis (LOS)10004018
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
- Neonates with gestational age <30 weeks
- suspected of late onset sepsis with blood drawn for blood culture and
inflammatory biomarkers
- IL-6 > 500 pg/ml and/or CRP > 50 mg/L
- PTX therapy cannot be started within 24 hours of start of antibiotic
treatment.
- Patients with known 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dose optimisation will be based on the clinical and biochemical (CRP, IL-6,<br /><br>PCT, TNF-a) response after 3 days in comparison to baseline and on adverse drug<br /><br>effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters include the evaluation of longitudinally determined<br /><br>91 inflammatory markers (Olink proteomics) and metabolomics of the whole<br /><br>inflammatory panel, to further understand the inflammatory and immunological<br /><br>changes of preterm infants during sepsis with PTX treatment and the<br /><br>pharmacokinetics of PTX and its metabolites in preterm infants. A target<br /><br>concentration of PTX and its metabolites will be calculated and PK/PD model for<br /><br>PTX will be developed. </p><br>