Molecular Culture for the Diagnosis of Pediatric Sepsis

Launched by JIP GROEN · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new test called Molecular Culture, which aims to improve the way doctors diagnose sepsis in babies and children. Sepsis is a serious condition caused by infections that can affect the bloodstream, and it can be hard to identify because its symptoms can look like those of other illnesses. Currently, doctors take a blood sample to check for bacteria, but this can take more than 36 hours, during which children often receive antibiotics that may not be needed. The new test could give results in just 4 hours, helping doctors determine if an infection is present much faster.

To participate in this study, children from birth up to 17 years old who are already having a blood sample collected for the usual blood culture test may be eligible. Participants will have their blood tested using both the new Molecular Culture test and the standard method. It's important to note that children with certain conditions, like specific infections or autoimmune diseases, may not be included in the study. This trial could help reduce unnecessary antibiotic use in children, protecting their healthy gut bacteria and fighting against antibiotic resistance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• * 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