| CTRI Number |
CTRI/2025/02/081452 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
RSV Burden estimation in the population
|
|
Scientific Title of Study
|
Respiratory syncytial virus (RSV): Burden estimation and the development of a monoclonal antibody-based point of care diagnostic |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No. 108
Manipal Institute of Virology,
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922663 |
| Fax |
08202922719 |
| Email |
anup.jayaram@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No. 108
Manipal Institute of Virology,
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922663 |
| Fax |
08202922719 |
| Email |
anup.jayaram@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No. 108
Manipal Institute of Virology,
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922663 |
| Fax |
08202922719 |
| Email |
anup.jayaram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Other [Research Body under Government of India] |
|
|
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 Muralidhar Varma |
Kasturba Medical College, Manipal |
Room No.3, Department of Infectious Disease, KMC Manipal, Karnataka
Udupi
KARNATAKA |
9845069639
08202922817
muralidhar.varma@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ILI and SARI symptoms admitted to KMC Manipal |
|
| ExclusionCriteria |
| Details |
Patients with chronic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Understanding the burden of RSV in the community |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predict the Seasonality of RSV |
36 Months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
18/03/2025 |
| 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 Yet Recruiting |
| 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
|
In India, there is not enough documentation on RSV epidemiology/ disease
burden. This may hinder and delay the decision-making process for
evidence-based policy decisions on any new RSV vaccine/immunotherapies. Here we plan
to determine the proportion of RSV among respiratory infections across the
geographic regions and in patients with various co-morbidities to provide a
comprehensive representation of the burden of RSV. Establishing a point-of-care diagnosis in the health
care setting can improve clinical management of the patient.
Study
Objectives:
To
estimate the burden of respiratory syncytial virus disease among different age groups
To
study the molecular epidemiology of respiratory syncytial virus and to evaluate
the severity associated with genotype
Development
of a monoclonal antibody-based rapid diagnostic kit for respiratory syncytial
virus |