Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04034264
Collaborator
(none)
5,500
4
59.3
1375
23.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characterization of Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing
    Actual Study Start Date :
    Jul 23, 2019
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Afebrile close contact

    Lived in the same household or worked in the same enclosed workspace daily with a febrile enrollee at the time they got sick with a known red or yellow flag transmissible pathogen.

    Febrile patient

    Patients between 2 months and 65 years old who present with fever.

    Outcome Measures

    Primary Outcome Measures

    1. Identification of pathogen sequences via IDseq analysis. [Enrollment (between Day 0-2)]

      This is an attempt to characterize what fraction of unexplained febrile illness is vector-borne in peri-urban Cambodia. Data from this study will be used to guide future studies.

    Secondary Outcome Measures

    1. Assessment of reactivity to salivary gland homogenate reactivity of appropriate vector as detected by ELISA or Western blot assays. [Enrollment (between Day 0-2)]

      Characterizing vector salivary protein reactivity profiles (mosquitos, ticks, fleas) in Cambodians with vector-borne disease is the first step to better understanding transmission patterns, responsible vectors, and Cambodian people s risk of exposure to these vectors.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.

    Meets one of the following case definitions:
    • Febrile patient: has documented fever equal to or greater than 38 (Infinite)C in 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 investigator, would interfere with participation in the study (e.g. inability or great difficulty in drawing blood).

    Any febrile individual who has had surgery in the prior month.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kampong Speu Referral Hospital Chbar Mon Cambodia
    2 Cambodian Center for Communicable Disease (CCDC) Phnom Penh Cambodia
    3 National Malaria Center (CNM), Ministry of Health (MOH) Phnom Penh Cambodia
    4 National Maternal and Child Health Center Phnom Penh Cambodia

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Jessica E Manning, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT04034264
    Other Study ID Numbers:
    • 999919109
    • 19-I-N109
    First Posted:
    Jul 26, 2019
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Jun 13, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022