Molecular Culture for diagnosing neonatal sepsis

Molecular Culture for the Diagnosis of Neonatal Sepsis: Towards Faster Recognition of Uninfected Neonates and Better Antibiotic Stewardship

This study tests a new method to quickly diagnose bacterial infections in newborns with suspected sepsis to see if it can help reduce unnecessary antibiotic use.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: N/A to 90 Days
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Veldhoven)
• Trial ID: NCT05763680 on ClinicalTrials.gov

What this trial studies

This observational study aims to improve the early diagnosis of neonatal sepsis, a condition that can be life-threatening for newborns. It evaluates a novel molecular culture technique that can identify bacterial infections within 4 hours, significantly faster than traditional blood cultures, which take 36-72 hours. By providing quicker results, the study seeks to reduce unnecessary antibiotic exposure in infants who are not infected. The study includes neonates with a gestational age greater than 24 weeks who are undergoing evaluation for early or late-onset sepsis.

Who should consider this trial

Good fit: Ideal candidates for this study are neonates over 24 weeks gestational age who are being evaluated for early or late-onset sepsis.

Not a fit: Patients with congenital TORCHES infections are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of sepsis in newborns, reducing unnecessary antibiotic treatments.

How similar studies have performed: While traditional methods have limitations, this novel molecular culture approach is relatively untested in this specific context.

Eligibility criteria

Inclusion Criteria:

* Gestational age \>24 weeks
* Neonates who receive a work up for early onset sepsis (including blood sampling for conventional culture) , either based on risk factors or clinical signs (according to local treatment guidelines) OR
* Infants who receive a work (including blood sampling for conventional culture) up for late onset sepsis

Exclusion Criteria:

* For neonates suspicious of having early onset sepsis: congenital TORCHES infection (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus and Treponema pallidum (Syphilis)

Where this trial is running

Veldhoven

• Maxima Medisch Centrum — Veldhoven, Netherlands (Recruiting)

Study contacts

• Principal investigator: Tim GJ de Meij, MD, PhD — Pediatric Gastro-enterologist
• Study coordinator: Jip Groen, MD

Conditions Neonatal Sepsis, Early-Onset; Culture Positive Neonatal Sepsis; Culture Negative Neonatal Sepsis; Clinical Sepsis; Microbial Disease; Neonatal Infection; Microbial Colonization; Neonatal Sepsis, Late-Onset