An observational study in Bloodstream Infection, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 1 site in United States. Open to participants aged Up to 24 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by St. Jude Children's Research Hospital · Observational
The majority of children and adolescents diagnosed with cancer will experience one or more episodes of fever or infection during their course of therapy. The most common microbiologically documented infection is bloodstream infection (BSI), which can be associated with severe sepsis or death. Current methods of diagnosis require a significant load of live bacteria in the blood making early detection difficult. Delayed diagnosis and delayed optimal therapy of BSIs are associated with increased morbidity and mortality.
This study seeks to identify whether next generation sequencing (NGS) of pathogens can identify patients with impending bloodstream infection. This would enable preemptive targeted therapy to replace antibacterial prophylaxis which often leads ot high-density broad-spectrum antibiotic exposure and contributes to subsequent development of antibiotic resistance.
PRIMARY OBJECTIVE:
Plasma samples collected but not required for clinical care (discarded samples) will be collected and stored. Results of NGS will be compared between patients who develop BSI immediately (within 72 hours) after sample collection, those who develop other infectious syndromes, and those who remain well. Clinical data describing baseline information about the patient and malignancy, antibiotic and chemotherapy exposure, microbiology testing, hematology results, and infection-related events will be collected prospectively from the electronic medical record.
An initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. The study may then enroll up to 200 participants to collection additional data for analysis.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 160 is close to the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who are being treated at St. Jude Children's Research Hospital and who have a high risk of infection.
Exclusion Criteria:
Proportion of NGS-positive results
To estimate the sensitivity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-positive results in all positive BSI cultures will be given.
Time frame: Once (within 72 hours of enrollment)
Proportion of NGS-negative results
To estimate the specificity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-negative results in all negative BSI cultures will be given.
Time frame: Once (within 72 hours of enrollment)
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital