Etiology of Febrile Illness in Nepal (DEFINe Study)

NCT07004751 | Recruiting

• 1 other identifier: DEFINe Study
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Febrile Illness; Fever Without Source

Keywords

Febrile Illnes

Outcome Measures

Primary Outcomes (2)

• Estimate the etiology of fever

  To estimate the proportion of additional infectious etiologies of febrile illness among patients presenting with an undifferentiated fever of 3 to 21 days duration.

  0-21 days

• Efficacy of antimicrobials

  Average number of antimicrobials prescribed to participants diagnosed solely based on clinical diagnosis versus those with additional microbiological testing.

  0-21 days

Secondary Outcomes (3)

• appropriateness of the empiric antibiotic therapy

  0-21 days

• correlation of clinical diagnosis with laboratory diagnosis

  0-21 days

• Compare the Treatment outcome

  0-21 days

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of care evaluation of a febrile patient is done by the treating medical team which usually consists of the following set of clinical, basic laboratory, radiological and microbiological evaluations: History and Evaluation; Basic Lab Tests; Radiological Investigations; Routine Serologies; Microbiological Investigations

Diagnostic Test: Standard of Care (SOC)

Study Arm

EXPERIMENTAL

For patients without an obvious cause of fever and an inconclusive work up after standard of care evaluations, additional serological tests as a part of undifferentiated febrile illness work up will be performed including clinical evaluation; additional microbiological evaluation and laboratory testing other than that in the standard care

Diagnostic Test: Additional laboratory analysis

Interventions

Additional laboratory analysis DIAGNOSTIC_TEST

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

Study Arm

Standard of Care (SOC) DIAGNOSTIC_TEST

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

Standard of Care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead

Study Sites (1)

Patan Academy of Health Sciences

Lalitpur, Bagmati, 44709, Nepal

RECRUITING

Study Officials

• Janak Koirala, MD MPH

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janak Koirala, MD MPH FIDSA

CONTACT

+9779818762117; janakkoirala@pahs.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Infectious diseases

Model Details: For patients without an obvious cause of fever and an inconclusive work up after standard of care evaluations, additional serological tests as a part of undifferentiated febrile illness work up will be performed including clinical evaluation; additional microbiological evaluation and laboratory testing

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 4, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)