Pentoxifylline Dose Optimization in Neonatal Sepsis

• Status: Recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX). Knowledge about optimal dosing is however limited. This study is a dose optimization study using a step-up and step-down model. In order to find the optimal dose, the infusion of pentoxifylline in different dosages will be studied, next to antibiotics with 3 patients per dosage. After the dose optimization study an additional cohort of 10 patients will be treated with the found dosage as a validation of the dose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Pentoxifylline

Criteria

Inclusion Criteria:

• Preterm born 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

Exclusion Criteria:

• pentoxifylline therapy cannot be started within 24 hours of start of antibiotic treatment.

• Major congenital defect (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies).

• IL-6 values exceeding 25000 pg/mL at time of onset. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates.

• Already participated in this trial during an earlier episode of late onset sepsis.

• PH below 7 in two consecutive blood samples, with at least 1 hour between the blood samples, at start of sepsis episode.