| CTRI Number |
CTRI/2024/05/067907 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the spread of respiratory syncytial virus (RSV) among children in KMC Manipal, Karnataka from June 2024 to October 2024 |
|
Scientific Title of Study
|
Determining the prevalence and molecular epidemiology of respiratory syncytial virus (RSV) in pediatric population at KMC, Manipal, Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Manipal Institute of Virology |
| Address |
Office of the Director, 1st floor, Manipal Institute of Virology, Manipal Academy of Higher Education, Madhavnagar, Manipal - 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Vojjila Sanjana Arunkumar |
| Designation |
Student |
| Affiliation |
Manipal Institute of Virology |
| Address |
Demonstration room, 1st floor, Manipal Institute of Virology, Manipal Academy of Higher Education, Madhavnagar, Manipal - 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7738544748 |
| Fax |
|
| Email |
vojjila.mivmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vojjila Sanjana Arunkumar |
| Designation |
Student |
| Affiliation |
Manipal Institute of Virology |
| Address |
Demonstration room, 1st floor, Manipal Institute of Virology, Manipal Academy of Higher Education, Madhavnagar, Manipal - 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7738544748 |
| Fax |
|
| Email |
vojjila.mivmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Institute of Virology, Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Manipal Institute of Virology, Manipal Academy of Higher Education, Madhavnagar, Manipal - 576104, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ms Vojjila Sanjana Arunkumar |
Kasturba Hospital, Manipal |
Department of Pediatrics, Kasturba Hospital, Kasturba Medical College, Tiger circle, Manipal - 576104, Karnataka
Udupi
KARNATAKA |
7738544748
vojjila.mivmpl2022@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: J210||Acute bronchiolitis due to respiratory syncytial virus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic children below 5 years with an acute respiratory infection (ARI), severe acute respiratory infection (SARI), or lower respiratory infection (LRTI), admitted to the pediatric department at Kasturba Hospital. |
|
| ExclusionCriteria |
| Details |
Patients above 5 years of age and patients with non-consenting parents or guardians. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine disease prevalence and prevalent
genotype of Respiratory Syncytial virus (RSV) circulating in Manipal, Karnataka.
|
at hospital admission.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/06/2024 |
| 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="0"
Months="4"
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
|
This study involves collecting 100 biological samples [Nasopharyngeal swab, throat swab, nasal swab in Viral Transport Medium (VTM)]. The study population includes symptomatic children under the age of five with Acute Respiratory Infection (ARI)/Severe Acute Respiratory Infection (SARI)/Lower Respiratory Tract Infection (LRTI) attending the Pediatric Department at KMC hospital, Manipal. With the samples collected, an extraction process will be carried out followed by the detection of RSV-specific RNA using real-time RT-PCR, semi-nested conventional PCR, Sanger Sequencing, and Phylogenetic analysis of the
strains. All the procedures mentioned will be performed at the laboratory of the Manipal Institute of Virology with good laboratory practice following all biosafety protocols. The genotyping study of RSV will give information on the currently circulating genotypes, their prevalence, and distribution patterns in the selected study population during the study period. The data obtained from this study will be informative for better diagnostic approaches and future surveillance of RSV. These findings will contribute to our understanding of the burden of RSV infection in this population. |