| CTRI Number |
CTRI/2025/08/092539 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between presence of amount of Pneumococcus bacteria in presence and/ or absence Of
Respiratory Viruses In Under-Five Children
|
|
Scientific Title of Study
|
Association Of Pneumococcal
Nasopharyngeal Carriage Density With Presence Of
Respiratory Viruses In Under-Five Children
|
| 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 Noor |
| Designation |
Post Graduate Year 1, Department of Microbiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi 110002
India
Central
DELHI
110002
India |
| Phone |
9255496118 |
| Fax |
|
| Email |
noorkadianmalik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi 110002
India
Central
DELHI
110002
India |
| Phone |
8368572214 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Noor |
| Designation |
Post Graduate Year 1, Department of Microbiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi 110002
India
DELHI
110002
India |
| Phone |
9255496118 |
| Fax |
|
| Email |
noorkadianmalik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Microbiology
Maulana Azad Medical College
New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Department of Microbiology |
| Address |
Department of Microbiology
Maulana Azad Medical College
BSZ marg, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Noor |
Maulana Azad Medical College, New Delhi |
Department of Microbiology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi
Delhi
Central
DELHI |
9255496118
noorkadianmalik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College, Institutional Ethics Committee, New Delhi 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J09-J18||Influenza and pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
There will be 3 groups in the study of which the first group will include under 5 children coming to the OutPatientDepartment for Acute Respiratory Infections. The second group will contain children with the admitting diagnosis of Pneumonia and Meningitis. The third group will be of healthy children. |
|
| ExclusionCriteria |
| Details |
1. Children with known immunodeficiency disorders
2. Known history of epistaxis
3. Known case of bleeding diathesis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The variation in pneumococcal carriage density in presence and / or absence of respiratory viruses in the nasopharynx of under five children |
One Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The association between carriage of pneumococcal serotypes to that causing invasive pneumococcal disease |
1 year |
| The variation in pneumococcal density with specific viral presence in the nasopharynx of under-5 children. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
18/08/2025 |
| 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="1"
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
|
This study will generate data on the mean pneumococcal carriage density due to presence of respiratory viruses in the nasopharynx of under five children. It will also generate data on the association between carriage of pneumococcal serotypes to that causing invasive pneumococcal disease. The variation in pneumococcal density with specific viral presence in the nasopharynx of under-5 children will also be elucidated. |