Status:
RECRUITING
Molecular Culture for the Diagnosis of Pediatric Sepsis
Lead Sponsor:
Jip Groen
Collaborating Sponsors:
InBiome
Conditions:
Sepsis
Sepsis Bacterial
Eligibility:
All Genders
Up to 18 years
Brief 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 th...
Detailed Description
Newborns and children often receive antibiotics for a suspicion of sepsis. Sepsis has high morbidity and mortality in newborns and children. Up to 50% of children in the Netherlands are prescribed at ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
1835 Patients enrolled
Trial Details
Trial ID
NCT06018792
Start Date
March 10 2024
End Date
November 1 2027
Last Update
April 10 2024
Active Locations (2)
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1
Amsterdam UMC
Amsterdam, Netherlands
2
Spaarne Gasthuis
Haarlem, Netherlands