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CTRI Number  CTRI/2025/03/082030 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to differentiate between scrub typhus and leptospirosis infections 
Scientific Title of Study   A study to assess the disease severity among scrub typhus and leptospirosis patients using clinical, immunological, and molecular tools 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavitha Saravu 
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical college Manipal 
Address  Room No 2 Department of Infectious Diseases Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal - 576104 Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax    
Email  kavitha.saravu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavitha Saravu 
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical college Manipal 
Address  Room No 2 Department of Infectious Diseases Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal - 576104 Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax    
Email  kavitha.saravu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kavitha Saravu 
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical college Manipal 
Address  Room No 2 Department of Infectious Diseases Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal - 576104 Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax    
Email  kavitha.saravu@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), Department of Health Research V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  ICMR Small Extramural funding scheme 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavitha Saravu  Kasturba Medical College and Hospital  Room 2, Department of Infectious Diseases, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 		 09448107636

kavitha.saravu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants with no history of fever for the past month will be enrolled as healthy controls. 
Patients  (1) ICD-10 Condition: A270||Leptospirosis icterohemorrhagica, (2) ICD-10 Condition: A279||Leptospirosis, unspecified, (3) ICD-10 Condition: A753||Typhus fever due to Rickettsia tsutsugamushi,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with suspected or confirmed diagnosis of scrub typhus and leptospirosis.
For healthy controls, participants with no history of fever for the past month 
 
ExclusionCriteria 
Details  Pregnant women, Individuals with coinfections, immunocompromised, and autoimmune disorders  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understanding the predictors to distinguish between scrub typhus and leptospirosis based on clinical, laboratory, and immunological profile  2nd year 
 
Secondary Outcome  
Outcome  TimePoints 
Understanding the importance/role of corticosteroids in the management of severe
scrub typhus patients

Development and Standardization of Multiplex PCR for early detection of scrub typhus 		 3rd Year 
 
Target Sample Size   Total Sample Size="311"
Sample Size from India="311" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Scrub typhus and leptospirosis are zoonotic acute undifferentiated febrile illnesses often associated with similar clinical manifestations and risk factors. Both illnesses can range from self-limiting to severe disease and multi-organ failure. If left untreated, scrub typhus can lead to death in 30-35% of cases, while severe leptospirosis has a case fatality rate ranging from 5-20%. The confirmatory tests for scrub typhus and leptospirosis, which are IFA and MAT, are time-consuming, expensive, require experienced laboratory personnel, and are unsuitable for early detection. Due to the cross-reactivity between these tests, there may be a significant overlap and misclassification in serological tests. The association between the host immune response and disease severity might help to better understand the pathogenesis of these infections. Determining the predictors of disease severity that can be used as a biomarker to distinguish between scrub typhus and leptospirosis might help in choosing empirical antibiotics. However, no studies have explored the cytokine profile in both infections, which could serve as a prognostic marker to improve patient management in severe conditions.
The current study aims to determine the association between disease severity and laboratory, molecular, and immune profiles in scrub typhus and leptospirosis. Additionally, the study determines the novel target gene combinations with optimal sensitivity and specificity for the early diagnosis of scrub typhus disease.

 
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