Actively Recruiting

Age: 0Years - 18Years
All Genders
NCT06018792

Molecular Culture for the Diagnosis of Pediatric Sepsis

Led by Jip Groen · Updated on 2024-04-10

1835

Participants Needed

2

Research Sites

190 weeks

Total Duration

On this page

Sponsors

J

Jip Groen

Lead Sponsor

I

InBiome

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Molecular Culture for the Diagnosis of Pediatric Sepsis

Who Can Participate

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Apart from an age criterion, there are no strict exclusion criteria. However, for the analysis of the secondary outcome (I.e. the testing of diagnostic accuracy of both MC as well as conventional culture for clinical sepsis), we plan to exclude all children who ultimately have a clear alternative cause for clinical illness that does not directly result from bacteraemia or bacterial sepsis. This will remain true in the case of conventional culture positivity, either when considered a contaminant as well as when considered a contributing factor in the presence of any of the causes of clinical illness mentioned below. A potential subject who meets any of the following criteria will be excluded from participation in this study These causes include, but are not limited to:
  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

2

Spaarne Gasthuis

Haarlem, Netherlands

Actively Recruiting

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Research Team

T

Tim de Meij, MD, PhD

CONTACT

J

Jip Groen, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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