Better dosing of pentoxifylline for preterm newborns with severe infections.

Phase 1

• Conditions: eonatal late onset sepsis; MedDRA version: 20.1Level: LLTClassification code 10053598Term: Late onset neonatal sepsisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-002020-33-NL
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-30
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Neonates with gestational age <30 weeks
- Suspected of sepsis with blood drawn for blood culture and inflammatory biomarkers
- IL-6 > 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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified