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RECRUITING
NCT06018792

Molecular Culture for the Diagnosis of Pediatric Sepsis

Sponsor: Jip Groen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

1835

Start Date

2024-03-10

Completion Date

2027-11-01

Last Updated

2024-04-10

Healthy Volunteers

Not specified

Interventions

DIAGNOSTIC_TEST

Molecular 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