Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 at least 2 months 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated ICF.
Stated willingness to comply with all study procedures.
Male or female, aged at least 2 months
Febrile patient: has documented fever equal to or greater than 38 degrees celsius in previous 24 hours.
Disqualifiers
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 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.
Trial population
Febrile patients who have documented fever equal to or greater than 38 degrees celsius in previous 24 hours, or those with a highly morbid and/or transmissible pathogen detected using standard clinical tests, who present at a hospital. If there is a highly morbid and/or transmissible pathogen identified from the febrile patient, close contacts will be identified through discussion with the patient.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
6,500 Participants
are grouped into 2 trial groupsGroup A: Afebrile close contact
Group B: Febrile patient
Trial outcomes
Primary outcomes
1
Identification of pathogen sequences
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.
Time frame
Enrollment (between Day 0-2)Secondary outcomes
1
Assessment of reactivity to salivary gland homogenate reactivity of appropriate vector as detected by ELISA or Western blot assays.
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.
Time frame
Enrollment (between Day 0-2)Sponsors and contacts
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Source ClinicalTrials.gov