Using presepsin to reduce unnecessary antibiotics in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the biomarker presepsin in reducing unnecessary antibiotic exposure in preterm infants born before 32 weeks gestational age who are at moderate risk for early-onset neonatal sepsis. The study will involve 874 subjects and will compare the outcomes of infants receiving standard care with those receiving presepsin as part of their treatment protocol. By integrating this biomarker into the existing Dutch guidelines, the researchers hope to decrease the rate of antibiotic use by at least 30% without compromising patient safety. The trial will also include an observational cohort for infants at low and high risk of sepsis who will not be randomized.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infants born at a gestational age of 24+0 to 31 6/7 weeks
* Moderate risk of early-onset neonatal sepsis, i.e. infants who should be treated with empirical antibiotics based on the Dutch EOS guideline.

Exclusion Criteria:

* low risk of early-onset neonatal sepsis who do not have an indication for empirical antibiotics according to the Dutch EOS guideline;
* high risk of early-onset neonatal sepsis defined as:

  1. suspected or confirmed diagnosis of maternal sepsis;
  2. suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection;
  3. unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2\>0.40 or non-invasive ventilation with FiO2 \>0.60 at time of randomization;
  4. ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization;
  5. strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone).

Where it's running

• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Douwe Visser, MD PhD — Amsterdam UMC
• Study coordinator: Douwe Visser, MD PhD
• Email: d.h.visser@amsterdamumc.nl
• Phone: +31205669111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.