Next Generation Pathogen Sequencing for Prediction of Adverse Events
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|ClinicalTrials.gov Identifier: NCT03226158|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : December 3, 2020
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.
- 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.
|Condition or disease|
Plasma samples collected but not required for clinical care (discarded samples) will be collected and stored. Results of NGS will be compared between patients who develop BSI immediately (within 72 hours) after sample collection, those who develop other infectious syndromes, and those who remain well. Clinical data describing baseline information about the patient and malignancy, antibiotic and chemotherapy exposure, microbiology testing, hematology results, and infection-related events will be collected prospectively from the electronic medical record.
An initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. The study may then enroll up to 200 participants to collection additional data for analysis.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||May 14, 2021|
|Estimated Study Completion Date :||May 14, 2021|
- Proportion of NGS-positive results [ Time Frame: Once (within 72 hours of enrollment) ]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.
- Proportion of NGS-negative results [ Time Frame: Once (within 72 hours of enrollment) ]To estimate the specificity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-negative results in all negative BSI cultures will be given.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226158
|Contact: Joshua Wolf, MBBS, BAemail@example.com|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Joshua Wolf, MBBS, BA 866-278-5833 firstname.lastname@example.org|
|Principal Investigator: Joshua Wolf, MBBS, BA|
|Principal Investigator:||Joshua Wolf, MBBS, BA||St. Jude Children's Research Hospital|