Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    5500
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 27 July 2022
Accepts healthy volunteers

Summary

Background

Vector-borne diseases are caused by the bite of an infected mosquito, fly, flea, tick, or other blood-feeder. These diseases cause almost 1 million deaths per year. And they are on the rise, particularly in Southeast Asia in particular. Researchers think that these diseases make up about 10 percent of fevers in Cambodia. But many of these illnesses are never diagnosed. Studying these diseases can help find new ways to identify and treat them.

Objective

To find pathogens in people who have a fever using metagenomic pathogen sequencing platforms.

Eligibility

People aged 6 months to 65 years with a fever of at least 38 degrees Celsius who visit the referral hospital in Cambodia

Design

Participants will be screened with their medical history. Children will be weighed to make sure they are big enough to give blood samples.

Participants will share data about their sex, age, and where they live. They will answer more questions about their heath history. They will answer questions about and any places to which they have recently traveled. They will take a questionnaire. They will have a blood test.

Participants aged 2 years or older who test positive for malaria will have one more blood test.

Participation will last up to 2 days....

Description

Vector-borne diseases continue to cause significant global morbidity and mortality, particularly in Southeast Asia. However, given a lack of diagnostics available in resource-poor countries, many vector borne diseases are never diagnosed and therefore their impact is underappreciated. Cross sectional retrospective surveys have revealed higher than expected antibody prevalence to a number of diseases including mosquito-borne viruses and ectoparasite borne rickettsial diseases.

Here, we aim to collect specimens from febrile individuals to better describe the febrile disease landscape of Cambodia using novel genomics technologies (unbiased next-generation sequencing) to investigate possible infectious etiologies of illnesses of unexplained etiology in Cambodian children and adults. If sequencing identifies a highly transmissible pathogen of public health concern, we will take a convalescent sample from the individual and screen his/her close contacts with serological assays to add an additional layer of understanding to the disease burden. With the current rise of vector-borne diseases around the world, we hope the results of this study contribute to better understanding the epidemiology and burden for vector-borne diseases in this region.

Details
Condition Vector-Borne Diseases
Clinical Study IdentifierNCT04034264
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the
following criteria
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures
Male or female, aged 6 months to 65 years, with documented fever equal or greater than 38
degrees Celsius in previous 24 hours
Willing to allow biological samples to be stored for future research and for all
de-identified metagenomic sequencing data to be stored in publicly accessible databases
Febrile patient: has documented fever equal to or greater than 38 (Infinite)C in
Meets one of the following case definitions
previous 24 hours
Afebrile close contact: is an afebrile individual who lived in the same household or
worked in the same enclosed workspace on a daily basis with a febrile enrollee at the
time they got sick with a known red or yellow flag transmissible pathogen on
metagenomic sequencing
Willing to allow biological samples to be stored for future research and for all
de-identified metagenomic sequencing data to be stored in publicly accessible databases

Exclusion Criteria

Any underlying, chronic, or current medical condition that, in the opinion of the
Any febrile individual who has had surgery in the prior month
investigator, would interfere with participation in the study (e.g. inability or great
difficulty in drawing blood)
Any febrile individual who enrolled and exited this study within 30 days of the initial
study blood draw, or afebrile close contact who enrolled and exited within 14 days
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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