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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Nepal
Patan Academy of Health Sciences
RECRUITING
Lalitpur
Contact Information
Primary
Janak Koirala, MD MPH FIDSA
janakkoirala@pahs.edu.np
+9779818762117
Time Frame
Start Date: 2025-07-04
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 194
Treatments
Active_comparator: Standard of Care
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
Experimental: Study Arm
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
Sponsors
Leads: Patan Academy of Health Sciences

This content was sourced from clinicaltrials.gov