Exploring febrile diseases in Cambodia using advanced pathogen sequencing
Characterization of Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing
National Institutes of Health Clinical Center (CC) · NCT04034264
This study is trying to find out what germs are causing fevers in people of all ages in Cambodia to help improve diagnosis and treatment of these illnesses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6500 (estimated) |
| Ages | 2 Months to 65 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 6 sites (Chbar Mon and 5 other locations) |
| Trial ID | NCT04034264 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify pathogens in individuals with fever in Cambodia through metagenomic pathogen sequencing. It focuses on vector-borne diseases, which are prevalent in the region but often go undiagnosed due to limited diagnostic tools. Participants aged 2 months to 65 years with a fever of at least 38 degrees Celsius or those diagnosed with specific pathogens will be enrolled. The study will collect biological samples to better understand the febrile disease landscape and potentially identify new pathogens of public health concern.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 months to 65 years with a documented fever or those diagnosed with a pathogen of concern.
Not a fit: Patients without fever or those not in close contact with individuals diagnosed with red flag pathogens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostics and treatment strategies for vector-borne diseases in Cambodia.
How similar studies have performed: Other studies using metagenomic sequencing for pathogen identification have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 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 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.
Where this trial is running
Chbar Mon and 5 other locations
- Kampong Speu Referral Hospital — Chbar Mon, Cambodia (RECRUITING)
- Kantha Bopha Hospital — Phnom Penh, Cambodia (RECRUITING)
- Khmer-Soviet Friendship Hospital — Phnom Penh, Cambodia (RECRUITING)
- National Pediatric Hospital — Phnom Penh, Cambodia (RECRUITING)
- Preah Kossomak Hospital — Phnom Penh, Cambodia (RECRUITING)
- Takeo District Referral Hospital — Takeo, Cambodia (RECRUITING)
Study contacts
- Principal investigator: Christina C Yek, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Christina C Yek, M.D.
- Email: christina.yek@nih.gov
- Phone: (202) 359-2641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vector-Borne Diseases, Emerging Pathogens, Next-Generation Sequencing, Southeast Asia, Agnostic Tools, Febrile Surveillance, Natural History