An interventional study of Additional laboratory analysis and Standard of Care (SOC) in Febrile Illness and Fever Without Source, sponsored by Patan Academy of Health Sciences. Recruiting at 1 site in Nepal. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Patan Academy of Health Sciences · Not applicable, Interventional, and Diagnostic
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.
Nepal is located between latitudes 26° and 31°N while its altitude ranges from 60m to 8848m from sea level allowing for a large variation in climate. Southern part of Nepal has tropical climate suitable for vector-borne tropical diseases whereas northern parts have more temperate and sub-arctic climate where these diseases are less common. Additionally, water-borne diseases have persisted because of a lack of sanitation and safe drinking water. Most hospitals in Nepal lack support of well equipped. microbiology laboratories for diagnosis of infectious diseases, and hence, most clinicians treat their patients empirically based on their decisions on clinical features alone . A study done in the region has shown poor predictability of clinical features alone to distinguish enteric fever from other causes of febrile illness .
Either from the lack of or limited access to confirmatory microbiological tests, majority of the cases of febrile illnesses in Nepal are diagnosed on clinical basis only. These cases of "undifferentiated fever" or "undifferentiated febrile illness" are treated empirically without etiological diagnosis. In the absence of correct diagnosis, patients receive multiple empirical antibiotics which increase the risk of antibiotic resistance and adds unnecessary burden of cost to the patients and their families. A hospital-based study of febrile patients published in 2004 revealed identifiable causes in only 37% of the patients.
The most common causes of febrile illness in Nepal at the time were enteric fever, murine typhus, scrub typhus, Leptospirosis, and bacterial infections including Streptococcus pneumoniae, Staphylococcus aureus, and Escherichia coli. Studies show a trend in increasing cases of rickettsial infections including Rickettsia typhi and Orientia tsutsugamushi.
Preliminary work done at Patan Hospital Patan Hospital is a tertiary care medical center with 450 beds that admits between 10 to 30 febrile patients per week depending on the season. Over 30% of these patients do not have localizing signs and symptoms for clinical diagnosis nor do they have a laboratory-based diagnosis. These cases are labelled as undifferentiated fever and receive empirical treatment with two or more antimicrobial agents. Previous studies done at Patan Hospital have demonstrated that Salmonella typhi and Salmonella paratyphi A were causes of undifferentiated fever of >3 days duration in 34% patients and Rickettsia typhi in 17% cases, whereas another study in 2008 found 7% cases of febrile illness has Rickettsia typhi, which is the cause of Murine typhus. These studies show an increase in cases of rickettsial infections including Riackettsia typhi and Orientia tsutsugamushi. Studies at Patan Hospital have also identified Streptococcus pneumoniae, Leptospira spp., Orientia tsutsugamushi, Hantavirus, and Coxiella burnetii as casues of febrile illnesses .
Research Gap The epidemiology of infectious disease has changed with massive within country urban migrations, increased migrant workers to India and overseas countries, change in climate, and several other reasons. Previous common causes of febrile illnesses such as malaria and enteric fever have declined over past decade whereas dengue and scrub typhus are on the rise. Meanwhile, new diseases such as COVID-19, dengue, and Scrub typhus have become commonplace [5,10,11]. Other causes of febrile illnesses, such as zoonoses (e.g. bartonellosis and Q fever), rickettsial (e.g. Q fever), and viral infections (e.g. arboviruses) remain mostly undiagnosed. This study aims to fill the gap in research by identifying additional causes and estimating burden of these infectious diseases. This will also help to reduce the unnecessary use of antibiotics.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 194 is above the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Patan Academy of Health Sciences is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
Additional lab tests will be done to establish the diagnosis of Murine typhus, Bartonellosis, Q-fever, Chikungunya, Zika, Japanese B encephalitis, West Nile virus
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
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.
Time frame: 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.
Time frame: 0-21 days
appropriateness of the empiric antibiotic therapy
Percentage of participants receiving empiric antibiotic treatment with the final laboratory-confirmed diagnosis.
Time frame: 0-21 days
correlation of clinical diagnosis with laboratory diagnosis
Percentage of cases where the initial clinical diagnosis matches the laboratory-confirmed diagnosis.
Time frame: 0-21 days
Compare the Treatment outcome
Percentage of participants who gets clinical recovery by Day 21, comparing those treated based on microbiological diagnosis versus clinical diagnosis alone.
Time frame: 0-21 days
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Jul 2026, 12 months after the start.
Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.
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Patan Academy of Health Sciences