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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Spaarne Gasthuis
RECRUITING
Haarlem
Contact Information
Primary
Tim de Meij, MD, PhD
t.demeij@amsterdamumc.nl
+3120 566 9111
Backup
Jip Groen, MD
j.groen5@amsterdamumc.nl
+3120 566 9111
Time Frame
Start Date: 2024-03-10
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 1835
Treatments
Pediatric sepsis
Study participants aged 3 months - 18 years who undergo collection of blood for conventional blood culture
Late onset sepsis
Study participants aged up to 3 months who undergo culturing of blood for conventional blood culture Preterm infants aged \<32 weeks gestational age as a subgroup
Early onset sepsis
Study participants aged up to 3 days who undergo culturing of blood for conventional blood culture
Post antibiotic initiation cohort
participants for whom venipuncture is performed for follow up of inflammatory parameters \<36h after antibiotic initiation and blood draw for conventional culture or for whom a repeat intravenous catheterization is performed due to failing of a previous one \<36h after antibiotic initiation and blood draw for conventional culture
Related Therapeutic Areas
Sponsors
Leads: Jip Groen
Collaborators: InBiome

This content was sourced from clinicaltrials.gov