| CTRI Number |
CTRI/2024/09/073454 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find respiratory viruses among severe respiratory illness patients |
|
Scientific Title of Study
|
Identification of respiratory viruses among SARI patients using real-time
PCR and third generation sequencing for development of molecular
respiratory panel |
| 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 Anitha J |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No.111 Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
08202922663 |
| Fax |
08202922718 |
| Email |
anitha.j@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anitha J |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No.111 Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
08202922663 |
| Fax |
08202922718 |
| Email |
anitha.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anitha J |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No.111 Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
08202922663 |
| Fax |
08202922718 |
| Email |
anitha.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Directorate of Research
Ground Floor, Tower 3, Behind Melaka Manipal Medical College, (MMMC)
Advanced Research Center, Manipal Academy of Higher Education, Manipal- 576104, Udupi, India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Directorate of Research, MAHE, Manipal - 576104 |
| 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 |
| Dr Anitha J |
Manipal Institute of Virology |
Room No. 111 Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka - 576104
Udupi
KARNATAKA
Udupi
KARNATAKA |
9986403225
08202922718
anitha.j@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHE Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be recruited as per the WHO SARI case definition - "An acute respiratory infection patients with the history of fever (≥ 38°C) and cough within the last 10 days and are hospitalized" and regardless of age, gender or any other underlying health condition. |
|
| ExclusionCriteria |
| Details |
Patients who do not meet the WHO SARI case definition will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Understanding the seasonality and prevalence of various respiratory viruses causing SARI in
Manipal can help in designing better public health intervention strategies |
Within 10 days of the onset of the illness |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study aims to estimate the prevalence of common respiratory viruses among SARI patients in Manipal, by establishing a third-generation sequencing platform for direct sequencing of clinical samples and developing a molecular respiratory panel for rapid virus identification. The methodology includes collecting 200 throat/nasopharyngeal swab samples from Kasturba hospital, Manipal and, performing nucleic acid extraction and real-time PCR, and sequencing using Oxford Nanopore technology for both PCR-positive and negative samples. The resulting data will be used in the development of a molecular respiratory virus panel |