| CTRI Number |
CTRI/2026/01/101365 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study Acute Respiratory infections in children using genetic material |
|
Scientific Title of Study
|
Clinical Presentation and Laboratory Characterization of Respiratory Microbial Colonization
and Antimicrobial Resistance Profile in children aged 03-60 months with
Acute Respiratory Infections attending OPD at Government Medical
College Nagpur, Maharashtra, using Metagenomics Next Generation
Sequencing approach: A cross-sectional, observational study.
|
| Trial Acronym |
ARI_mNGS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Patel |
| Designation |
Program Director |
| Affiliation |
LATA MEDICAL RESEARCH FOUNDATION |
| Address |
Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India |
| Phone |
07122249569 |
| Fax |
|
| Email |
dr_apatel@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAliabbas A Husain |
| Designation |
Research Consultant/ Professor and HOD |
| Affiliation |
CIIMS Nagpur |
| Address |
Advance Research Centre, central India Institute of Medical Sciences, 93, Bajaj Nagar, Nagpur 440010.
And
Department of Pediatrics, GMC, Nagpur
Nagpur
MAHARASHTRA
440010
India |
| Phone |
9730648481 |
| Fax |
|
| Email |
aliabbashusain23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Tiwari |
| Designation |
HOD Pediatrics |
| Affiliation |
Government Medical College |
| Address |
Pediatrics Department,
Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9552526538 |
| Fax |
|
| Email |
manishtiwari.peds@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Intra mural funding between Lata medical research foundation and Central India institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Lata Medical Research Foundation |
| Address |
9/1, inkine utir, Vasant Nagar, Nagpur |
| Type of Sponsor |
Other [Not-for-Profit Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr GM Taori Central India Institute of Medical Sciences |
93, Bajaj Nagar, Nagpur 22 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish Tiwari |
Government Medical College, Nagpur |
Department of Pediatrics, Govt. Medical College, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA |
9552526538
manishtiwari.peds@rediffmail.com |
| Dr Archana Patel |
Lata Medical Research Foundation |
9/1, Kinkini Kutir, Vasant Nagar
Near Hanuman Temple
Nagpur
MAHARASHTRA |
07122249569
dr_apatel@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Review Committee Lata Medical Research Foundation |
Approved |
| Institutional Ethics Committee Department of Pharmacology , Govt. Medical College, Nagpur |
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 |
3.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
1) Presenting with clinical symptoms of acute respiratory infection (ARI)
2) Seeking care at a participating study site i.e. GMCH Nagpur
3)Parent/legal guardian willing to provide consent for participation, including sample collection
|
|
| ExclusionCriteria |
| Details |
1) Prior enrolment in this study
2) Presence of any conditions/ criteria that preclude the participation in the study as per investigator’s judgment
3) Already enrolled in other research study/ clinical trial
4) Consent refusal
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of respiratory microbiome and AMR profile |
End of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Valuable insights into the epidemiology and etiology of respiratory infections in children. |
End of the study |
| Differences in clinical presentation of ARI in children with different possible causative pathogens. |
End of study |
| Development of evidence-based policies for the prevention and management of ARI, as well as antimicrobial stewardship strategies. Ultimately, these efforts aim to reduce morbidity and mortality associated with ARI in children across India |
End of the study |
|
|
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)
|
27/01/2026 |
| 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="6"
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
|
Title: Clinical Presentation and Laboratory of Respiratory Microbial colonization and Antimicrobial Resistance Profile in children aged 03-60 months with acute Respiratory Infection Attending OPD at Government Medical college Nagpur, Maharashtra, using Metagenomics Next Generation Sequence approach: A cross-sectional, observational study. Population:100 children (03-60 months) Intervention : None Objectives: Aim 1: To use mNGS technology to analyze nasopharyngeal samples from paediatric population aged 03 to 60 months with ARI, to identify possible etiological cause of ARI and its association with clinical presentations in children attending tertiary care hospital in Nagpur. Aim2: To study drug sensitivity profile among pediatric groups to antimicrobial and antivirals for AMR determination and risk assessment Aim3: To characterization of the microbial population and their seasonal variations Design/Methodology: This is a cross-sectional, observational, exploratory study design, to study the microbial colonization in nasopharyngeal (NP) swabs using mNGS techniques in children aged 03 to 60 months with ARI attending the pediatric outpatient department at Government Medical College & Hospital, Nagpur. There is no intervention involved in this study, so it does not meet the definition of a clinical trial with study arms. Total Study Duration: 6 months Subject Participation Duration: one time, at enrollment |