InfectionNCT02912117
Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
An observational study of Infection and Neutropenia, run by Karius, Inc. at 1 site in United States.
Trial summary
Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Neutropenia
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted for fever and neutropenia at the Stanford University Hospital or patients who are admitted for chemotherapy who develop fever and neutropenia at Stanford University Hospital.
Who may be able to join
- 18 years of age
- Are or will be admitted to Stanford University Hospital for fever and neutropenia
- Neutropenia - an absolute neutrophil count of <500 per cubic mm
- Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia
Who cannot join
- Inability to understand instructions and comply with study-related procedures
- Any condition that in the opinion of the treating physician will prevent the subject from completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospital
Stanford, California, 94305
About this study
Official title: Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.
- Conditions
- Infection, Neutropenia
- Medical subject headings
- Infections, Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karius, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Stanley C Deresinski, MD, Principal investigator, Stanford UniversityJose G Montoya, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912117
- Sponsor's protocol ID
- 004-CL-01
- Status last verified
- Mar 2018
- First submitted
- 19 Sep 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Benamu E, Gajurel K, Anderson JN, Lieb T, Gomez CA, Seng H, Aquino R, Hollemon D, Hong DK, Blauwkamp TA, Kertesz M, Blair L, Bollyky PL, Medeiros BC, Coutre S, Zompi S, Montoya JG, Deresinski S. Plasma Microbial Cell-free DNA Next-generation Sequencing in the Diagnosis and Management of Febrile Neutropenia. Clin Infect Dis. 2022 May 3;74(9):1659-1668. doi: 10.1093/cid/ciab324.
PubMed 33870413
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
- ClinicalTrials.gov ID
- NCT02912117
- Acronym / sponsor ID
- 004-CL-01
- Conditions
- Infection, Neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Karius, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted for fever and neutropenia at the Stanford University Hospital or patients who are admitted for chemotherapy who develop fever and neutropenia at Stanford University Hospital.
Key inclusion criteria (4 listed)
- 18 years of age
- Are or will be admitted to Stanford University Hospital for fever and neutropenia
- Neutropenia - an absolute neutrophil count of <500 per cubic mm
- Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia
Key exclusion criteria (2 listed)
- Inability to understand instructions and comply with study-related procedures
- Any condition that in the opinion of the treating physician will prevent the subject from completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis
Time frame: 12 Months
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 11 May 2018.
- Derived from this study: PubMed 33870413Benamu E, Gajurel K, Anderson JN, Lieb T, Gomez CA, Seng H, Aquino R, Hollemon D, Hong DK, Blauwkamp TA, Kertesz M, Blair L, Bollyky PL, Medeiros BC, Coutre S, Zompi S, Montoya JG, Deresinski S. Plasma Microbial Cell-free DNA Next-generation Sequencing in the Diagnosis and Management of Febrile Neutropenia. Clin Infect Dis. 2022 May 3;74(9):1659-1668. doi: 10.1093/cid/ciab324.
- Individual participant dataSharing planned: Undecided
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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.
Stanley C Deresinski, MD principal investigator
Stanford University
Jose G Montoya, MD principal investigator
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 Infection and Neutropenia, 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 4 inclusion and 2 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 11 May 2018. 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?
Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912117, which also lists 1 linked publication.
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 11 May 2018.