| CTRI Number |
CTRI/2025/01/079277 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Kidney involvement in patients with leptospirosis: a prospective cohort study |
|
Scientific Title of Study
|
Prevalence and Predictors of kidney involvement in patients with leptospirosis: a prospective cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASTHA SETHI |
| Designation |
PhD scholar |
| Affiliation |
KMC, Manipal |
| Address |
Department of infectious disease, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9653586937 |
| Fax |
|
| Email |
astha.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Gupta |
| Designation |
Associate professor, KMC, Manipal |
| Affiliation |
KMC, Manipal |
| Address |
Department of infectious disease, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9868996079 |
| Fax |
|
| Email |
nitin.gupta@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Gupta |
| Designation |
Associate professor, KMC, Manipal |
| Affiliation |
KMC, Manipal |
| Address |
Department of infectious disease, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9868996079 |
| Fax |
|
| Email |
nitin.gupta@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka,India, 576104, 092437 77700 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Madhav Nagar, Manipal, Karnataka,India, 576104, 092437 77700 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Astha Sethi |
Kasturba Medical College and Hospital |
Room no 4, Department of infectious disease, Manipal, Karnataka, India, 576104
Udupi
KARNATAKA |
9653586937
astha.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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are IgM Elisa positive for leptospirosis |
|
| ExclusionCriteria |
| Details |
History of pre-existing kidney disease
Structurally abnormal kidney on ultrasound
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Chronic Kidney Disease (CKD) at 1 year
|
Chronic Kidney Disease (CKD) at 1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Chronic Kidney Disease (CKD) will be assessed at 3 months & 1 year & Acute Kidney Injury at baseline |
Incidence of Chronic Kidney Disease (CKD) will be assessed at 3 months & 1 year & Acute Kidney Injury at baseline |
|
|
Target Sample Size
|
Total Sample Size="218"
Sample Size from India="218"
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)
|
20/02/2025 |
| 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) |
Open to Recruitment |
|
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
|
Primary objective Incidence and Predictors of CKD in microbiologically proven
leptospirosis without any pre-existing kidney dysfunction at three months and one
year. In India, where leptospirosis is endemic, there is a critical gap in directly determining
the prevalence and predictors of kidney involvement in leptospirosis patients. A
6
prospective cohort study would involve following a group of patients over time
after a leptospirosis infection to track their kidney function and identify any long
term complications. Such a study would provide valuable data on the incidence of
chronic kidney issues post-infection, as well as factors (such as patient
demographics, severity of initial infection, or co-morbidities) that might predict who
is at greater risk of persistent dysfunction |