NCT03226158Active, not recruiting
Next Generation Pathogen Sequencing for Prediction of Adverse Events
Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 160 (actual)
- First submitted
- 20 Jul 2017
- Start date
- 9 Aug 2017
- Primary completion date
- 1 Mar 2022
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT03226158
What you commit to
- Study type: Observational
- Participants enrolled: 160
- From 9 Aug 2017 to the primary completion date, 1 Mar 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Who the study is looking for
- 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
Age in the registry: - to 24 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
Related publications
- Predicting bloodstream infection by plasma cell-free metagenomic sequencing: a prospective cohort study.Lancet Microbe · 2026 · PMID 41780551
This page is information, not medical advice. Discuss any trial with your doctor.