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Detection of Dengue Virus in Plasma of Patients in Nepal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620487
Recruitment Status : Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Karius, Inc.

Tracking Information
First Submitted Date May 11, 2018
First Posted Date August 8, 2018
Last Update Posted Date August 6, 2019
Actual Study Start Date December 21, 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Dengue Virus in Plasma of Patients in Nepal
Official Title Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Subjects with Dengue or Dengue Fever-like illnesses in Nepal.
Condition Dengue Fever
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 6, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Nepal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03620487
Other Study ID Numbers 012-DL-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karius, Inc.
Study Sponsor Karius, Inc.
Collaborators Tribhuvan University, Nepal
Investigators
Principal Investigator: Krishna Manandhar, PhD Tribhuvan University
PRS Account Karius, Inc.
Verification Date August 2019