CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Pentoxifyllinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04152980
NCT04152980Phase 3Completed
CompareCT.gov

Pentoxifylline Dose Optimization in Preterm Neonatal Late Onset Sepsis

Erasmus Medical Center·interventional·Posted Nov 6, 2019·Updated Aug 9, 2024

In Brief

A Phase 3 clinical trial evaluating Pentoxifylline for Neonatal Late Onset Sepsis. Completed, enrolled 30 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Late Onset Sepsis
CountriesNetherlands, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartJan 12, 2020
Primary CompletionOct 31, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.7 years ago

Interventions

Pentoxifyllinedrug

The intervention consists of intravenously administered pentoxifylline. Pentoxifylline , a methylxanthine, is an off patent drug for neonates and currently registered for peripheral artery disease treatment in adults. Pentoxifylline acts as a cyclic adenosine monophosphate(cAMP)-phosphodiesterase inhibitor that suppresses tumor necrosis factor alfa (TNF-α) and modulates important parts of the inflammatory response and also reduces the production of other inflammatory cytokines, such as IL-1α, IL-6, and IL-8.