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NCT03620487 Clinical Trial

Detection of Dengue Virus in Plasma of Patients in Nepal

Dengue Fever Clinical Trial

Official title:
Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03620487
Other study ID # 012-DL-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2016
Est. completion date July 31, 2020

Study information
Verified date February 2023
Source Karius, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 643
Est. completion date July 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Nepal Tribhuvan University Kirtipur

Sponsors (2)
Lead Sponsor Collaborator
Karius, Inc. Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 years
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