ClinicalTrials.gov
ClinicalTrials.gov Menu

Next Generation Pathogen Sequencing for Prediction of Adverse Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03226158
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Karius, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief 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.

Condition or disease
Bloodstream Infection

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020



Primary Outcome Measures :
  1. 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.

  2. 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
Plasma samples collected but not required for clinical care will undergo next generation pathogen sequencing.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who are being treated at St. Jude Children's Research Hospital and who have a high risk of infection.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Joshua Wolf, MBBS, BA 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Joshua Wolf, MBBS, BA    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Joshua Wolf, MBBS, BA         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Karius, Inc.
Investigators
Principal Investigator: Joshua Wolf, MBBS, BA St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03226158     History of Changes
Other Study ID Numbers: PREDSEQ
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Next generation pathogen sequencing (NGPS)
Pediatric
Cancer
Bloodstream infection (BSI)

Additional relevant MeSH terms:
Infection