Detection of Dengue Virus in Plasma of Patients in Nepal | NCT03620487

Studies
Detection of Dengue Virus in Plasma of Patients in Nepal

NCT03620487

Sponsor

Karius, Inc.

Status

Completed

Last Update Posted

Feb 14, 2023Actual

Enrollment

643Actual

Phase

Not provided

Conditions

Dengue Fever

Interventions

Not provided

Countries

Nepal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2016Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

May 11, 2018

First Submission Date that Met QC Criteria

Aug 6, 2018

First Posted Date

Aug 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 14, 2023Actual

Name	Class
Tribhuvan University, Nepal	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

643Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with Dengue or Dengue Fever-like illnesses in Nepal.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krishna Manandhar, PhD	Tribhuvan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tribhuvan University		Ki̇̄rtipur			Nepal

Condition Browse Module

MeSH Terms

ID	Term
D003715	Dengue

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

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Browse Branches

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