RecruitingNot ApplicableNCT07004751

Etiology of Febrile Illness in Nepal (DEFINe Study)

Determination of Etiology of Febrile Illness in Nepal (DEFINe Study)


Sponsor

Patan Academy of Health Sciences

Enrollment

194 participants

Start Date

Jul 4, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 16 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

DIAGNOSTIC_TESTAdditional laboratory analysis

Additional lab tests will be done to establish the diagnosis of Murine typhus, Bartonellosis, Q-fever, Chikungunya, Zika, Japanese B encephalitis, West Nile virus

DIAGNOSTIC_TESTStandard of Care (SOC)

Standard of care evaluation of a febrile patient is done by the treating medical team as Standard of care evaluation of a febrile patient is done by the treating medical team which includes clinical, basic laboratory, radiological and microbiological evaluations


Locations(1)

Patan Academy of Health Sciences

Lalitpur, Bagmati, Nepal

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NCT07004751