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.
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
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
All minors aged \<18 years
Cohort
Prospective
Molecular Culture
Diagnostic testPCR 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.
diagnostic accuracy of MC for the result of the conventional blood culture in newborns and children suspected of sepsis
We will analyse test characteristics and provide test sensitivity, specificity and positive and negative predictive values. Based on previous studies, we hypothesize that MC will be positive in all samples that are positive by conventional blood culture. We hypothesize that MC will yield more false positives or contaminants than conventional culture.
diagnostic accuracy of MC for (clinical) sepsis and compare this with the diagnostic accuracy of the conventional blood culture for (clinical) sepsis.
Clinical sepsis will be defined varyingly given lack of an international clinical syndrome definition
diagnostic accuracy of MC on blood samples drawn after initiation of empirical antibiotics, for the result of the conventional blood culture in samples, drawn at initial sepsis workup
we aim to study pathogen detectability loss, due to antibiotic administration
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Jip Groen
Lead sponsor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Sponsor institution
InBiome
Collaborator
