NeutropeniaNCT03530072
Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients
An observational study of Neutropenia and Fever, run by Karius, Inc. at 1 site in United States.
Trial summary
Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care requires admission of all patients for intravenous antibiotics until cultures are negative, patients are afebrile and there are signs of bone marrow recovery. Read more about this study
- Who is it for?
- Ages 1 year to 22 years
- Conditions the study is for
- Neutropenia, Fever
- What is being tested?
- Karius Test
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children being admitted for inpatient treatment with fever and neutropenia.
Who may be able to join
- 1) Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH)
Who cannot join
- Relapsed disease
- Acute lymphoblastic leukemia during induction
- Acute myeloid leukemia during any phase of treatment
- Philadelphia-chromosome positive ALL
- Down syndrome
- Patients who have received an allogeneic stem cell transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hopsital
Stanford, California, 94304
About this study
Official title: Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study
Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care requires admission of all patients for intravenous antibiotics until cultures are negative, patients are afebrile and there are signs of bone marrow recovery. This often results in prolonged hospital admissions with significant financial costs, decreased quality of life and potential secondary infections. More recent data suggests it may be possible to identify a "low risk" group that can be discharged prior to signs of bone marrow recovery. At this time, researchers have been unable to identify a model that is safe for early discharge across institutions.
Read the detailed description
- Conduct a pilot study to determine the feasibility of using the Karius Assay to risk stratify pediatric oncology patients admitted with febrile neutropenia. This will provide preliminary data for a larger study which would randomize patients to early discharge vs. usual care.
- Evaluate the Klaasen and SPOG clinical decision rules with and without the Karius Assay to predict patients at low risk for adverse infectious outcomes during admission. Adverse infectious outcome will be defined as: positive blood or urine culture, radiographic evidence of infection, admission to the intensive care unit or death.
- Model potential cost savings of early discharge for patients deemed low risk for an adverse infectious outcome.
- Conditions
- Neutropenia, Fever
- Being tested
- Karius Test
- Medical subject headings
- Neutropenia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karius TestDiagnostic test
Next Generation Sequencing
| Study group | Role | What they receive |
|---|---|---|
| Cases | Subjects with Fever and Neutropenia Receives: Diagnostic Test: Karius Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modeled sensitivity and specificity
Sensitivity, specificity, PPV, NPV of Klassen and SPOG clinical decision rules with and without incorporation of Karius test for prediction of patients at low risk for infectious outcomes during hospital admission. Assessed at time of Discharge
Measured: 1 day of Discharge
Secondary outcomes (1)
Modeled cost savings
Estimate cost savings for hospital stay with and without Karius results at time of discharge.
Measured: 1 day of Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start7 May 2018
- Primary completion1 Aug 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karius, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Catherine Aftandillian, MD, Principal investigator, Lucille Packard Children's Hospital/Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530072
- Sponsor's protocol ID
- KDP-005
- Status last verified
- Feb 2023
- First submitted
- 7 May 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study
- ClinicalTrials.gov ID
- NCT03530072
- Acronym / sponsor ID
- KDP-005
- Conditions
- Neutropenia, Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karius, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care requires admission of all patients for intravenous antibiotics until cultures are negative, patients are afebrile and there are signs of bone marrow recovery. This often results in prolonged hospital admissions with significant financial costs, decreased quality of life and potential secondary infections. More recent data suggests it may be possible to identify a "low risk" group that can be discharged prior to signs of bone marrow recovery. At this time, researchers have been unable to identify a model that is safe for early discharge across institutions.
Detailed description
- Conduct a pilot study to determine the feasibility of using the Karius Assay to risk stratify pediatric oncology patients admitted with febrile neutropenia. This will provide preliminary data for a larger study which would randomize patients to early discharge vs. usual care.
- Evaluate the Klaasen and SPOG clinical decision rules with and without the Karius Assay to predict patients at low risk for adverse infectious outcomes during admission. Adverse infectious outcome will be defined as: positive blood or urine culture, radiographic evidence of infection, admission to the intensive care unit or death.
- Model potential cost savings of early discharge for patients deemed low risk for an adverse infectious outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Karius TestSubjects with Fever and Neutropenia |
Who may qualify
- Ages
- 1 year to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children being admitted for inpatient treatment with fever and neutropenia.
Key inclusion criteria (1 listed)
- 1) Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH)
Key exclusion criteria (6 listed)
- Relapsed disease
- Acute lymphoblastic leukemia during induction
- Acute myeloid leukemia during any phase of treatment
- Philadelphia-chromosome positive ALL
- Down syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karius TestNext Generation Sequencing | Diagnostic test | Cases |
Primary outcome
Modeled sensitivity and specificity
Time frame: 1 day of Discharge
Sensitivity, specificity, PPV, NPV of Klassen and SPOG clinical decision rules with and without incorporation of Karius test for prediction of patients at low risk for infectious outcomes during hospital admission. Assessed at time of Discharge
1 secondary outcome
Modeled cost savings
Time frame: 1 day of Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Aftandillian, MD principal investigator
Lucille Packard Children's Hospital/Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia and Fever, run by Karius, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modeled sensitivity and specificity (time frame: 1 day of Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.