Causes of unexplained fevers in Nepal (DEFINe)
Official title: Determination of Etiology of Febrile Illness in Nepal (DEFINe Study)
Run by Patan Academy of Health Sciences · NCT07004751 · Data updated 2026-11-12
This project will test whether adding cultures and ELISA blood tests can find the causes of fever and reduce unnecessary antibiotic use in adults admitted with 3–21 day unexplained fevers in Nepal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 194 (estimated) |
| Sponsor | Patan Academy of Health Sciences Academic / other |
| Locations | 1 site (Lalitpur, Bagmati) |
| Status | Recruiting |
| Started | July 4, 2025 |
| Main results expected | July 10, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT07004751 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 16 years or older admitted to the medical unit at Patan Academy with documented fever lasting 3–21 days, no obvious diagnosis after initial testing, and who can provide informed consent.
✕Probably not a fit
Outpatients, children under 16, immunocompromised individuals (including known HIV or ANC <500), patients with fevers shorter than 3 days or longer than 21 days, those being discharged from the emergency room, or recently hospitalized patients are not expected to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This hospital-based interventional effort enrolls adults with documented fevers of 3 to 21 days and no clear clinical, radiological, or routine laboratory diagnosis. Participants receive additional microbiological testing beyond local standard of care, including culture techniques and ELISA serology for seven pathogens not routinely tested in Nepal. The study compares etiologic detection and subsequent antimicrobial use when these additional tests are applied. Results will inform whether broader diagnostic testing changes treatment decisions and identifies otherwise-missed causes of febrile illness.
Why it matters
Potential benefit: If successful, this could let clinicians target treatment more accurately, reduce unnecessary antibiotic use and costs, and help slow antibiotic resistance.
How similar studies have gone: Previous regional studies have shown that adding microbiological testing can identify more causes of fever and reduce empirical antibiotic use, though this specific panel of tests has not been widely implemented in Nepal.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 16 years or older * Documented fever (T ≥100.4F or ≥38C) of 3 days to 21 days duration * No obvious diagnosis found on the basis of clinical, radiological, or initial routine laboratory tests\* * Admitted to the medical unit of hospital * Signed ICF (informed consent form) Exclusion Criteria: * Outpatients * Fever of less than 3 days or more than 21 days duration * Patients being discharged from Emergency Room * Children (younger than 16 years in age)\*\* * Immunocompromised patients * Neutropenia (ANC \<500 per cumm) * Known case of HIV infection * Admission to a hospital for 48-hours or longer within past 30 days
Where it's running
-
Patan Academy of Health Sciences
Lalitpur, Bagmati, Nepal Recruiting
Study contacts
- Principal investigator: Janak Koirala, MD MPH — Patan Academy of Health Sciences
- Study coordinator: Janak Koirala, MD MPH FIDSA
- Email: janakkoirala@pahs.edu.np
- Phone: +9779818762117
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.