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NCT03226158 · ClinicalTrials.gov registry record
Next Generation Pathogen Sequencing for Prediction of Adverse Events
A clinical trial of Bloodstream Infection, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- 160
- Enrollment target
- 1
- Study location
NCT03226158: Active study of Bloodstream Infection, sponsored by St. Jude Children's Research Hospital.
NCT03226158 is a study of Bloodstream Infection that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 160 participants, above the 35-participant average among 3 other Bloodstream Infection trials with a reported enrollment target (357% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03226158, a study of Bloodstream Infection, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 160 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2017-08-09 |
| Est. Completion | 2026-03-01 |
What the registry record for NCT03226158 still lists
NCT03226158 is an observational study that tracks outcomes without assigning an intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 35-participant average among 3 other Bloodstream Infection trials with a reported enrollment target (357% higher).
The record links to 1 condition, with Bloodstream Infection appearing as the primary indexed condition, and to 0 interventions.
NCT03226158 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03226158 about?
NCT03226158 is a clinical study titled "Next Generation Pathogen Sequencing for Prediction of Adverse Events". 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. Curren...
What is the current status of trial NCT03226158?
This trial is currently active not recruiting. The enrollment target is 160 participants. The study started on 2017-08-09. Estimated completion is 2026-03-01.
What conditions does trial NCT03226158 study?
This clinical trial studies the following conditions: Bloodstream Infection.
Who is sponsoring clinical trial NCT03226158?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03226158 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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