Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)

Status: Active_not_recruiting
Location: See location...
Study Type: Observational
SUMMARY

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: * To estimate the sensitivity and specificity of next generation pathogen sequencing for prediction of bloodstream infection in children with cancer at high risk of infection.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 24
Healthy Volunteers: f
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• Under 25 years of age at time of study enrollment

• Undergoing care for cancer at St. Jude

• In a category of patients who are considered by the investigator to be at high risk of infection

• Expected to receive care at St. Jude for at least 7 days

Locations
United States
Tennessee
St. Jude Children's Research Hospital
Memphis
Time Frame
Start Date: 2017-08-09
Completion Date: 2026-03-01
Participants
Target number of participants: 160
Related Therapeutic Areas
Sponsors
Leads: St. Jude Children's Research Hospital
Collaborators: Karius, Inc.

This content was sourced from clinicaltrials.gov