Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing
NCT ID: NCT04034264
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6500 participants
OBSERVATIONAL
2019-07-23
2026-07-01
Brief Summary
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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 2 months to 65 years with a fever of at least 38 degrees Celsius or those diagnosed with infection by a pathogen of concern who visit the referral hospital in Cambodia. Close contacts of people diagnosed with infection by a pathogen of concern may also be enrolled.
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. If they have respiratory symptoms, they will have a nasal swab.
Participants may be contacted within 1-2 weeks (early) and/or within 3 months (late) from their enrollment date to provide an optional follow-up blood samples and nasal swabs....
Detailed Description
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Here, we aim to collect specimens from individuals with acute febrile illness or red flag pathogens 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 a highly transmissible and/or highly virulent (red flag) pathogen of public health concern is identified, we will take a convalescent sample from the individual and screen his/her close contacts with serological and molecular assays to add an additional layer of understanding of 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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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 highly morbid and/or transmissible pathogen.
No interventions assigned to this group
Febrile patient
Patients between 2 months and 65 years old who present with fever, or diagnosed with a highly morbid and/or transmissible pathogen by clinically validated tests.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures.
* Male or female, aged 2 months to 65 years.
* Meets one of the following case definitions:
* Febrile patient: has documented fever equal to or greater than 38 degrees celsius in previous 24 hours.
* Red flag patient: is an individual with disease relating to a red flag pathogen (see list, below), with confirmed standard laboratory testing (e.g., blood culture, polymerase chain reaction \[PCR\]) for the pathogen in question.
* 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 red flag patient at the time they got sick with a known pathogen.
* 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 febrile individual who has had surgery in the prior month.
* Any patient 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.
2 Months
65 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Christina C Yek, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Kampong Speu Referral Hospital
Chbar Mon, , Cambodia
Kantha Bopha Hospital
Phnom Penh, , Cambodia
Khmer-Soviet Friendship Hospital
Phnom Penh, , Cambodia
National Pediatric Hospital
Phnom Penh, , Cambodia
Preah Kossomak Hospital
Phnom Penh, , Cambodia
Takeo District Referral Hospital
Takeo, , Cambodia
Countries
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Central Contacts
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Facility Contacts
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Christina Yek, M.D.
Role: primary
Christina Yek, M.D.
Role: primary
Christina Yek, M.D.
Role: primary
Christina Yek, M.D.
Role: primary
Christina Yek, M.D.
Role: primary
Christina Yek, M.D.
Role: primary
References
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Vong S, Khieu V, Glass O, Ly S, Duong V, Huy R, Ngan C, Wichmann O, Letson GW, Margolis HS, Buchy P. Dengue incidence in urban and rural Cambodia: results from population-based active fever surveillance, 2006-2008. PLoS Negl Trop Dis. 2010 Nov 30;4(11):e903. doi: 10.1371/journal.pntd.0000903.
Gu W, Miller S, Chiu CY. Clinical Metagenomic Next-Generation Sequencing for Pathogen Detection. Annu Rev Pathol. 2019 Jan 24;14:319-338. doi: 10.1146/annurev-pathmechdis-012418-012751. Epub 2018 Oct 24.
Tabor A, Valle MR. Report from the 'One Health' 9th Tick and Tick-Borne Pathogen Conference and the 1st Asia-Pacific Rickettsia Conference, Cairns, Australia, 27th August-1st September 2017. Vet Sci. 2018 Oct 2;5(4):85. doi: 10.3390/vetsci5040085.
Other Identifiers
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19-I-N109
Identifier Type: -
Identifier Source: secondary_id
999919109
Identifier Type: -
Identifier Source: org_study_id