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NCT03226158
Next Generation Pathogen Sequencing for Prediction of Adverse Events
trial in Bloodstream Infection in 160 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2022
Quick facts
| Lead sponsor | St. Jude Children's Research Hospital |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 160 |
| Start date | 9 August 2017 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across United States |
Conditions studied
- Bloodstream Infection — all drugs for Bloodstream Infection →
Sponsor
St. Jude Children's Research Hospital
Who can join
Under 24, any sex, with Bloodstream Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Evaluation of Plasma Microbial Cell-Free DNA Sequencing to Predict Bloodstream Infection in Pediatric Patients With Relapsed or Refractory Cancer.
Goggin KP, Gonzalez-Pena V, Inaba Y, Allison KJ, et al · · 2020 · cited 96× · PMID 31855231 · DOI 10.1001/jamaoncol.2019.4120 -
Next-generation sequencing of microbial cell-free DNA for rapid noninvasive diagnosis of infectious diseases in immunocompromised hosts.
Camargo JF, Ahmed AA, Lindner MS, Morris MI, et al · · 2019 · cited 54× · PMID 31814964 · DOI 10.12688/f1000research.19766.4 -
Predicting bloodstream infection by plasma cell-free metagenomic sequencing: a prospective cohort study.
Wolf J, Goggin KP, Inaba Y, Allison KJ, et al · · 2026 · PMID 41780551 · DOI 10.1016/j.lanmic.2025.101312
Verify or expand the search:
- PubMed search for NCT03226158
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other St. Jude Children's Research Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03226158 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03226158.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing