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Study of laboratory diagnosis of leptospirosis and its characterization in tertiary care hospital setting.

Not Applicable
Conditions
Health Condition 1: A279- Leptospirosis, unspecified
Registration Number
CTRI/2019/01/017333
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Objective 1: To compare the various diagnostic tools for accurate diagnosis of human leptospirosis in patients presenting with acute febrile illness.Objective 2: To study serovar-specific clinical characteristics, complications and prognosis of infections by the predominant serovars.

Objective 3: Molecular characterization of Leptospira by Multilocus sequence typing (MLST).

Patients of both gender and >18 years of age presenting to the Kasturba Hospital, Manipal and diagnosed with Acute febrile illness (AFI) will be included in this study.

Fever of <14 days duration with any two of the following signs and symptoms. Myalgia, headache, jaundice, conjunctival suffusion, rash (maculopapular), hepatic dysfunction, GI symptoms (e.g., abdominal pain, nausea, vomiting, diarrhoea), pulmonary complications (ARDS), acute kidney injury (AKI), haemorrhage (e.g., intestinal, pulmonary, haematuria, hematemesis), aseptic meningitis.

Objective 4:

Sero-epidemiological study of human leptospirosis amongst high-risk population (farmers) of Udupi District.

Healthy farmers with no history of fever and antibiotic therapy in the previous two weeks and >18 years of age of both the gender will be included in the study.

Exclusion Criteria

Objective 1: To compare the various diagnostic tools for accurate diagnosis of human leptospirosis in patients presenting with acute febrile illness.

Objective 2: To study serovar-specific clinical characteristics, complications and prognosis of infections by the predominant serovars.

Objective 3: Molecular characterization of Leptospira by Multilocus sequence typing (MLST).

Cases known to have confirmed alternate diagnosis (typhoid, malaria, brucellosis, scrub typhus and dengue) and of <18 years of age will be excluded.

Objective 4:

Sero-epidemiological study of human leptospirosis amongst high-risk population (farmers) of Udupi District.

Farmers having chronic illness of chronic kidney disease, chronic liver disease and diabetes mellitus; history of fever in the previous two weeks; those who have received any antibiotic therapy in the previous two weeks and those of <18 years of age will be excluded from the study.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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