| CTRI Number |
CTRI/2025/08/093153 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
What makes Leptospirosis severe and how can we predict it with SPiRO score. |
|
Scientific Title of Study
|
Mortality and severity predictors of Leptospirosis and usefulness of SPiRO score. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriti Lakhotia |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College, Madhav Nagar,
Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7380563723 |
| Fax |
|
| Email |
sriti.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Bhat |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College, Madhav Nagar,
Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008576103 |
| Fax |
|
| Email |
nitin.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prithvishree Ravindra |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Emergency Medicine,
Kasturba Medical College, Madhav Nagar,
Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9035296971 |
| Fax |
|
| Email |
prithvishree.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine and Department of Emergency Medicine
Kasturba Medical College
Madhav nagar Manipal
Karnataka 576104
India |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine |
| Address |
New OPD building, 2nd floor, Kasturba Medical College, Madhav Nagar, Manipal
Karnataka 576104
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Emergency Medicine |
Emergency Medicine, Kasturba Medical College, Madhav Nagar, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sriti Lakhotia |
Kasturba Hospital, Manipal |
Department of General Medicine and Department of Emergency Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
7380563723
sriti.kmcmpl2024@learner.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 - 2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A279||Leptospirosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged 18 years and above
2) Patients diagnosed with suspected, probable or confirmed leptospirosis based on WHO 2003 diagnostic criteria.
3) Hospitalized patients (those admitted for treatment and management of leptospirosis- related complications)
4) Availability of laboratory and clinical data, including parameters such as presence of Jaundice, Hemoptysis, Hypotension, Hematocrit levels, WBC count and platelet count. |
|
| ExclusionCriteria |
| Details |
1) Co-Infections – Patients with other infectious diseases that may affect prognosis (e.g., dengue, malaria).
2) Age – Below 18 years not included.
3) Clinical and Laboratory Data – Cases lacking sufficient clinical or laboratory data.
4) Pre-existing Medical Conditions – Patients with thalassemia, chronic kidney disease, or other serious underlying conditions.
5) Patients on Immunosuppressive Therapy – Those undergoing chemotherapy or immunosuppressive treatments that may alter the disease presentation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify clinical predictors of disease severity and mortality in Leptospirosis. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the prognostic utility of the Spiro Score in predicting disease severity & mortality in leptospirosis.
2) Analyze patient outcomes based on SPiRO Score categories to determine its practical usefulness.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="267"
Sample Size from India="267"
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)
|
06/09/2025 |
| 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="2"
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
|
This study is being performed to explore a set of parameters for predicting severe leptospirosis in adult patients Objectives are as follows To identify clinical predictors of disease severity and mortality in
Leptospirosis
To evaluate the prognostic utility of the
Spiro Score in predicting disease severity and mortality in leptospirosis
Analyze patient outcomes based on SPiRO
Score categories to determine its practical usefulness Patients aged 18 years and above with suspected,
probable, or confirmed leptospirosis will be recruited from OPD and IPD
settings between June 2025 and June 2027.Recruitment will follow eligibility
screening based on inclusion and exclusion criteria, with informed consent
obtained before enrolment. Initial assessment includes demographic data,
clinical history, vital signs, and laboratory tests completed within 24 hours
of admission. |