NCT04152980

Pentoxifylline Dose Optimization in Neonatal Sepsis

Completed Phase 3 Last updated 9 August 2024

What this trial tests

Phase 3 trial testing Pentoxifylline in Neonatal Late Onset Sepsis in 30 participants. Completed in 31 December 2022.

Timeline

12 January 2020

Primary endpoint
31 October 2022

31 December 2022

Quick facts

Lead sponsor	Erasmus Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	12 January 2020
Primary completion	31 October 2022
Estimated completion	31 December 2022
Sites	2 locations across Netherlands, Poland

Drugs / interventions tested

• Pentoxifylline — full drug profile →

Conditions studied

• Neonatal Late Onset Sepsis — all drugs for Neonatal Late Onset Sepsis →

Sponsor

Erasmus Medical Center

Who can join

Under 30 Weeks, any sex, with Neonatal Late Onset Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stratified Management for Bacterial Infections in Late Preterm and Term Neonates: Current Strategies and Future Opportunities Toward Precision Medicine.
   Keij FM, Achten NB, Tramper-Stranders GA, Allegaert K, et al · · 2021 · cited 7× · PMID 33869108 · DOI 10.3389/fped.2021.590969
2. Editorial: Sepsis in Neonates and Children.
   Giannoni E, Schlapbach LJ. · · 2020 · cited 7× · PMID 33330295 · DOI 10.3389/fped.2020.621663
3. Protocol: Pentoxifylline optimal dose finding trial in preterm neonates with suspected late onset sepsis (PTX-trial).
   Kurul S, Taal HR, Flint RB, Mazela J, et al · · 2021 · cited 6× · PMID 34794420 · DOI 10.1186/s12887-021-02975-8