RecruitingNot Applicable

Etiology of Febrile Illness in Nepal (DEFINe Study)

Nepal194 participantsStarted 2025-07-04

Plain-language summary

In the absence of a microbiological lab testing, majority of the cases of febrile illnesses in Nepal are diagnosed on a clinical basis alone. These cases of "undifferentiated febrile illness" are treated empirically with multiple antibiotics without an etiological diagnosis. Unnecessary use of antibiotics can increase the risk of antibiotic resistance and adds unnecessary burden of cost to the patients and their families. This study aims to determine the etiology of infections using additional microbiological techniques in patients admitted to the hospital with acute undifferentiated febrile illness of 3 days to 21 days duration, and assess its impact on use of antimicrobial drugs. In addition to the clinical features, the etiological diagnosis will be confirmed by using additional tests including culture techniques and ELISA based serological tests for 7 additional pathogens which are currently not tested in Nepal. Patients meeting definition of undifferentiated fever of 3 days to 21 days duration will be enrolled from a major tertiary care center using predefined inclusion and exclusion criteria.This study will help to identify additional infectious diseases prevalent in Nepal, decrease unnecessary empirical use of multiple antibiotics, and improve patient outcome. Additionally, identification of new causes of febrile illness will help in prevention and control of these infectious diseases at public health level.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimate the etiology of fever

Timeframe: 0-21 days

Efficacy of antimicrobials

Timeframe: 0-21 days

Trial details

NCT IDNCT07004751

SponsorPatan Academy of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-10

Contact for this trial

Janak Koirala, MD MPH FIDSA

+9779818762117 janakkoirala@pahs.edu.np

View on ClinicalTrials.gov More Febrile Illness trials