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Next Generation Pathogen Sequencing for Prediction of Adverse Events

NCT03226158 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Bloodstream Infection

Sponsors & Collaborators

Principal Investigators

  • Joshua Wolf, MBBS, BA · St. Jude Children's Research Hospital

Eligibility

Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-09
Primary Completion
2022-03-01
Completion
2026-07-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226158 on ClinicalTrials.gov