Using presepsin to reduce unnecessary antibiotics in preterm infants

Presepsin to Safely Reduce Antibiotics in Preterm Infants: a Randomized Controlled Trial

This study is testing if using a blood marker called presepsin can help reduce unnecessary antibiotic use in preterm infants at risk for infection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06100614 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at a gestational age of 24+0 to 31 6/7 weeks who are classified as moderate risk for early-onset neonatal sepsis.

Not a fit: Patients who are at low risk for early-onset neonatal sepsis or those at high risk requiring immediate antibiotic treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the unnecessary use of antibiotics in preterm infants, minimizing the risk of short- and long-term complications associated with antibiotic exposure.

How similar studies have performed: While the use of biomarkers in this context is innovative, similar studies have shown promise in reducing antibiotic use in other populations, suggesting potential for success.

Eligibility criteria

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 this trial is running

Amsterdam, North Holland

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Douwe Visser, MD PhD — Amsterdam UMC
• Study coordinator: Douwe Visser, MD PhD

Conditions Early-Onset Neonatal Sepsis; preterm infants; antibiotics; presepsin