Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT06018792
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
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT06018792
Study Brief:
Protocol Section:
NCT06018792