Detection of Dengue Virus in Plasma of Patients in Nepal
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ClinicalTrials.gov Identifier: NCT03620487 |
Recruitment Status : Unknown
Verified August 2019 by Karius, Inc..
Recruitment status was: Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : August 6, 2019
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Condition or disease |
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Dengue Fever |
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 Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal. |
Actual Study Start Date : | December 21, 2016 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | September 2020 |

- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.
Exclusion Criteria:
- 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.

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): NCT03620487
Nepal | |
Tribhuvan University | |
Kirtipur, Nepal |
Principal Investigator: | Krishna Manandhar, PhD | Tribhuvan University |
Responsible Party: | Karius, Inc. |
ClinicalTrials.gov Identifier: | NCT03620487 |
Other Study ID Numbers: |
012-DL-01 |
First Posted: | August 8, 2018 Key Record Dates |
Last Update Posted: | August 6, 2019 |
Last Verified: | August 2019 |
NGS Sequencing |
Dengue Fever Body Temperature Changes Arbovirus Infections Vector Borne Diseases Infections |
Virus Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |