Next Generation Pathogen Sequencing for Prediction of Adverse Events
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 24 |
| Updated: | 8/22/2018 |
| Start Date: | August 9, 2017 |
| End Date: | October 31, 2020 |
| Contact: | Joshua Wolf, MBBS, BA |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)
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.
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.
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.
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.
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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Joshua Wolf, MBBS, BA
Phone: 866-278-5833
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