RecruitingNCT06018792

Molecular Culture for the Diagnosis of Pediatric Sepsis

Children's Health Assessment and Molecular Pathogen Identification for Optimized Novel Sepsis Therapy


Sponsor

Jip Groen

Enrollment

1,835 participants

Start Date

Mar 10, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection. However, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.


Eligibility

Min Age: 0 YearsMax Age: 18 Years

Inclusion Criteria2

  • Undergoing collection of blood for a conventional blood culture as part of standard care OR
  • Having undergone sepsis evaluation collection of blood for a conventional blood culture as part of standard care in the past 72 hours

Exclusion Criteria4

  • In case of the potential inclusion of a neonate suspicious for EOS, confirmed congenital infection with TORCHES (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes) will lead to exclusion particularly for the neonatal population
  • Auto inflammatory disease
  • Hemophagocytic syndrome
  • SIRS (Systemic Inflammatory Response Syndrome following a severe viral infection

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Interventions

DIAGNOSTIC_TESTMolecular Culture

PCR based bacterial profiling technique, that creates a differentiating microbial signature based on amplification of the interspace region in bacterial ribosomal RNA. Results on gel capillary electrophoresis are analyzed with software to recognize these signatures.


Locations(2)

Amsterdam UMC

Amsterdam, Netherlands

Spaarne Gasthuis

Haarlem, Netherlands

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NCT06018792


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