| CTRI Number |
CTRI/2020/07/026640 [Registered on: 17/07/2020] Trial Registered Prospectively |
| Last Modified On: |
17/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing for leptospirosis infection in healthy donors |
|
Scientific Title of Study
|
A pilot study on screening of blood donors for emerging transfusion transmissible Leptospirosis infection in an endemic area. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Chenna |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, KMC, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
09901470899 |
| Fax |
|
| Email |
deepu.kkd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shamee Shastry |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, KMC, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9743489837 |
| Fax |
|
| Email |
shameeshastry@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deepika Chenna |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, KMC, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
09901470899 |
| Fax |
|
| Email |
deepu.kkd@gmail.com |
|
|
Source of Monetary or Material Support
|
| J. mitra & Company Pvt Ltd A-180-181 Okhla Industrial Area Phase 1 New Delhi 110020 India |
|
|
Primary Sponsor
|
| Name |
Directorate of Research Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education |
| Type of Sponsor |
Research institution |
|
|
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 |
| Deepika Chenna |
Katurba Hospital |
Blood Bank, Basement of trauma Triage Udupi KARNATAKA |
09901470899
deepu.kkd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kassturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Voluntary Blood Donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Blood donors who are residents of Udupi district only will be included. |
|
| ExclusionCriteria |
| Details |
Blood donors form other districts will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of leptospirosis infection would be studied, and the need for implementation of screening test for blood components. |
March 30 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the need for larger studies to evaluate the necessity of implementation of screening test for blood components. |
December 31 2020 |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
24/07/2020 |
| 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="1" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIl |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Emerging
infectious diseases pose threats to the general human population, including
recipients of blood transfusions. The risk of transmission of infection by
blood transfusion results from collecting of blood from an infected donor while
he is asymptomatic and the pathogen is present in his blood. The
microbiological safety of the blood supply is continuously improving. The major
focus has been HIV, hepatitis viruses and bacterial contamination. In fact,
there are many infectious agents that are known, or that have properties that
would predict the ability, to be transmissible by blood transfusion. A recent publication
listed some 68 infectious agents with this characteristic, but for which
interventions have not been implemented. [1] Leptospirosis is among such
infections and is endemic in Karnataka and Kerala and we have outbreaks of Leptospirosis
almost every year. The present study is planned to assess the need for
implementation of newer donor screening strategies for detection of
leptospirosis infection at our place. A prospective pilot study
enrolling 500 healthy voluntary blood donors will be done. The donor sample
will be collected after blood donation from the blood bag for screening of
transfusion transmissible infections (HIV, HBV, HCV, Malaria and Syphilis). In
addition to these mandatory screening tests we will be screening the sample for
Leptospirosis infection by detection of leptospira specific Ig M antibodies by
ELISA method. If a donor is found to be reactive, a confirmatory test would be
performed by rapid kits and donor notification and the components prepared will
be discarded |