Molecular culture for diagnosing sepsis in children
Children's Health Assessment and Molecular Pathogen Identification for Optimized Novel Sepsis Therapy
This study is testing a faster way to diagnose sepsis in newborns and children by using a new blood test to see if it can identify infections more quickly than the usual method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1835 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT06018792 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis of sepsis in newborns and children by utilizing a molecular culture method. Currently, blood cultures take 36-72 hours to yield results, leading to unnecessary antibiotic use in many cases. The study will involve collecting blood samples from children undergoing standard blood culture tests to evaluate the effectiveness of the molecular culture approach in identifying bacterial infections more rapidly. By comparing the results of molecular culture with conventional blood cultures, the study seeks to enhance diagnostic accuracy and reduce antibiotic overuse.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns and children who are undergoing blood tests for suspected sepsis as part of standard care.
Not a fit: Patients with clear alternative causes for their clinical illness that do not involve bacterial sepsis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate diagnoses of sepsis in children, reducing unnecessary antibiotic treatments.
How similar studies have performed: While the molecular culture approach is gaining traction, this specific application in pediatric sepsis diagnosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 1 other locations
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Spaarne Gasthuis — Haarlem, Netherlands (Recruiting)
Study contacts
- Principal investigator: Tim de Meij, MD, PhD — Amsterdam UMC
- Study coordinator: Tim de Meij, MD, PhD
- Email: t.demeij@amsterdamumc.nl
- Phone: +3120 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.