Molecular Culture for the Diagnosis of Pediatric Sepsis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorJip Groen

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Molecular Culture

Treatment groups

1,835 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Jip Groen

Lead sponsor

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Sponsor institution

InBiome

Collaborator