| CTRI Number |
CTRI/2025/05/086330 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of a Common Respiratory Virus (RSV) in Patients with Lung Infections |
Scientific Title of Study
Modification(s)
|
Incidence and Epidemiological Characterization of Respiratory Syncytial Virus: Molecular and Clinical Insights from Coastal Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Asmita B |
| Designation |
PG Student |
| Affiliation |
Manipal Institute of Virology |
| Address |
Room No: 01, Ground Floor, Manipal institute of Virolgy, Manipal Academy of Higher Education, Madhava Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8147810456 |
| Fax |
|
| Email |
asmita.mivmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology |
| Address |
Room No: 108, Ground Floor, Manipal institute of Virolgy, Manipal Academy of Higher Education, Madhava Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482406560 |
| Fax |
|
| Email |
anup.jayaram@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology |
| Address |
Room No: 108, Ground Floor, Manipal institute of Virolgy, Manipal Academy of Higher Education, Madhava Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482406560 |
| Fax |
|
| Email |
anup.jayaram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room No: 105, Manipal Institute of Virology, Manipal Academy of Higher Education, Madhava Nagar, Manipal, Udupi District, Karnataka State, India. Pincode: 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Institute of Virology |
| Address |
Room No: 105, Manipal institute of Virolgy, Manipal Academy of Higher Education, Madhava Nagar, Manipal, Udupi District, Karnataka State, India. Pincode: 576104 |
| 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 |
| Dr Muralidhar Varma |
Kasturba Hospital Manipal |
Room No: ID-03, Department of Infectious Diseases, KH, Manipal Academy of Higher Education, Madhava Nagar, Manipal
Udupi
KARNATAKA |
9845069639
muralidhar.varma@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC - KH INSTITUTIONAL ETHICS COMMITTEE - 2 - STUDENT RESEARCH |
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 |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Only symptomatic individuals with Acute respiratory infection (ARI)/ Severe Acute respiratory infection (SARI)/ Lower respiratory tract Infection (LRTI) from both inpatients and outpatients are considered. Along with the routine samples that come to the virology department for testing under the same case definition
Parents/guardians/attending physicians must provide informed consent for infants/children participants and for adult participants; they themselves must provide informed consent or their guardians/attending physicians must provide consent on behalf of them to participate in this study. |
|
| ExclusionCriteria |
| Details |
Individuals with a confirmed clinical diagnosis who do not fulfill the specified case definition.
Individuals who have not provided consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| This study will determine the prevalence and burden of RSV across all age groups, identify circulating RSV-A and RSV-B strains through partial genome sequencing, assess the correlation between RSV viral load and clinical outcomes using quantitative PCR, contribute to molecular surveillance, and support development of monoclonal antibodies targeting the RSV Fusion (F) protein for diagnostic and therapeutic applications. |
24 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will help us determine the prevalence, distribution, and burden of RSV infections
across all age groups, including vulnerable populations, providing key epidemiological data to
support public health strategies.
This study will help us identify and characterize circulating RSV strains (RSV-A and RSV-B)
through partial genome sequencing, tracking viral evolution, genetic diversity, and their
association with disease severity.
By this study we will be able to assess the correlation between RSV viral load and clinical
outcomes, such as disease severity and symptom duration, using standardized PCR
quantification.
Also, we can analyze seasonal trends and contribute to RSV molecular surveillance for early
outbreak detection and improved public health preparedness. |
12 Months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
13/05/2025 |
| 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
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Respiratory Syncytial virus (RSV) is one of the major causes of Acute Lower Respiratory Tract Infection (ALRTI) in infants and children’s (more severe in <1 year age), elderly adults, pregnant women and people with immune-compromised state. However, recent reports highlight that adult population (18-65 years age) also showing severe cases of lower respiratory tract infection due to RSV infection. Despite the significant impact, data on the age-stratified burden of Respiratory Syncytial Virus (RSV) and its molecular epidemiology remain limited, especially in diverse populations. This project seeks to explore the age-related burden of respiratory syncytial virus (RSV) and its molecular characteristics to better understand the factors for disease severity. By assessing the distribution of RSV infections across age groups, the study aims to quantify its impact in terms of incidence, hospitalization rates, and clinical outcomes. This will shed light on how RSV affects individuals differently based on age, ranging from infants to elderly adults, including previously healthy individuals who are now increasingly being reported with severe RSV-associated illnesses. The molecular characteristics of RSV will be studied to identify circulating genotypes and their evolutionary patterns. By using genomic sequencing, it will help us reveal how genetic variations influence disease outcomes, including whether specific genotypes are linked to severe manifestations like acute respiratory distress or complications requiring intensive care. The study outcomes are expected to inform future public health strategies, improve patient management, and support the global effort to combat RSV-related morbidity and mortality. |