Dengue FeverNCT03620487
Detection of Dengue Virus in Plasma of Patients in Nepal
An observational study of Dengue Fever, run by Karius, Inc. at 1 site in Nepal.
Trial summary
To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue Fever
- How many people
- 643 participants
- Where
- 1 siteNepal
- Study dates
- 26 Oct 2016to 31 Jul 2020
- 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: Subjects with Dengue or Dengue Fever-like illnesses in Nepal.
Who may be able to join
- 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.
Who cannot join
- Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that will prevent the subject from completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.
To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.
Read the detailed description
Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA.
The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.
- Conditions
- Dengue Fever
- Keywords
- NGS, Sequencing
- Medical subject headings
- Dengue
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Karius Test in detecting the Dengue Virus in plasma.
Test the sensitivity and specificity of the Karius Infectious Disease Diagnostic Sequencing Assay in detecting the Dengue Virus in plasma (measured in molecules per mL) from suspected cases of Dengue Virus from a hospital-based multicentered study conducted in Nepal.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start26 Oct 2016
- Primary completion31 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies 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
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karius, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tribhuvan University, Nepal
- Responsible party
- Sponsor
- Investigators
- Krishna Manandhar, PhD, Principal investigator, Tribhuvan University, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620487
- Sponsor's protocol ID
- 012-DL-01
- Status last verified
- Feb 2023
- First submitted
- 11 May 2018
- Last updated
- 14 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.
- ClinicalTrials.gov ID
- NCT03620487
- Acronym / sponsor ID
- 012-DL-01
- Conditions
- Dengue Fever
- Keywords
- NGS, Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Karius, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tribhuvan University, Nepal
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 8 Aug 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.
To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.
Detailed description
Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA.
The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.
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
- Subjects with Dengue or Dengue Fever-like illnesses in Nepal.
Key inclusion criteria (1 listed)
- 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.
Key exclusion criteria (1 listed)
- Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that 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 and Specificity of the Karius Test in detecting the Dengue Virus in plasma.
Time frame: 3 years
Test the sensitivity and specificity of the Karius Infectious Disease Diagnostic Sequencing Assay in detecting the Dengue Virus in plasma (measured in molecules per mL) from suspected cases of Dengue Virus from a hospital-based multicentered study conducted in Nepal.
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 14 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.
Krishna Manandhar, PhD principal investigator
Tribhuvan University, Nepal
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 Dengue Fever, run by Karius, Inc. at 1 site in Nepal.
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 1 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 14 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 Nepal. 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 and Specificity of the Karius Test in detecting the Dengue Virus in plasma. (time frame: 3 years). 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 14 Feb 2023.