| CTRI Number |
CTRI/2025/10/096408 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effects of different host factors and variation in cytomegalovirus genome on clinical presentation in children under 14years of age |
|
Scientific Title of Study
|
Effect of host factors and variations in viral genome on clinical characteristics in children infected with cytomegalovirus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Aditi |
| Designation |
MBBS Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 41, Department of Microbiology, Pathology Block, Maulana Azad Medical College, Balmiki Basti, New Delhi - 110002.
New Delhi
DELHI
110002
India |
| Phone |
011-23239271 |
| Fax |
|
| Email |
kumariaditi149209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 41, Department of Microbiology, Pathology block, Maulana Azad Medical College, Balmiki Basti, New Delhi - 110002.
New Delhi
DELHI
110002
India |
| Phone |
011-23239271 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 41, Department of Microbiology, Pathology block, Maulana Azad Medical College, Balmiki Basti, New Delhi - 110002.
New Delhi
DELHI
110002
India |
| Phone |
011-23239271 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council for Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council for Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029, India |
| 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 Vikas Manchanda |
Maulana Azad Medical College |
Room No. 41, Department of Microbiology, Pathology block, Maulana Azad Medical College, Balmiki Basti, New Delhi - 110002.
New Delhi
DELHI |
011-23239271
micromamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B108||Other human herpesvirus infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
CHILDREN DIAGNOSED WITH CMV INFECTION BY EITHER OF THE LABORATORY TESTS, NAMELY, CMV DNA PCR, OR ANTI- CMV IGM ANTIBODIES |
|
| ExclusionCriteria |
| Details |
Patients where the complete clinical records are not available 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 |
To describe the clinical characteristics in children diagnosed with cytomegalovirus
infection. |
3 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the spectrum of various genomes (viromes) of CMV strains isolated from infected
children. |
3 YEARS |
To determine association of viral genetic factors with the clinical manifestations in CMV-
infected children. |
3 YEARS |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
10/11/2025 |
| 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 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 unravel the clinical presentation of CMV infected children in Indian population. Further, the viral genetic determinants of clinical variability in CMV infections among children may be established. The research will be instrumental in the broader understanding of CMV pathogenesis and inform the development of targeted therapies and preventive measures. |