| CTRI Number |
CTRI/2025/11/097876 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study infections in Newborns by MiNION Technique |
|
Scientific Title of Study
|
Evaluation of Bacterial Infection and Antimicrobial Stewardship in Neonatal Sepsis in Nagpur district, Maharashtra using Nanopore Sequencing (MinION), System:) |
| Trial Acronym |
MinION |
|
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,
Research Department,
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 |
Dr Amit Nayak |
| Designation |
Research Scientist |
| Affiliation |
Advance Research Centre, Central India Institute of Medical Sciences |
| Address |
Central India Institute of Medical Sciences, Research Unit, 88/2, Bajaj Nagar, Nagpur 440010
Nagpur
MAHARASHTRA
440010
India |
| Phone |
0976793938 |
| Fax |
|
| Email |
amit_ciims@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Nayak |
| Designation |
Research Scientist |
| Affiliation |
Advance Research Centre, Central India Institute of Medical Sciences |
| Address |
Central India Institute of Medical Sciences, Research Unit,
88/2, Bajaj Nagar, Nagpur 440010
Nagpur
MAHARASHTRA
440010
India |
| Phone |
0976793938 |
| Fax |
|
| Email |
amit_ciims@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Intra mural funding
1.Lata Medical Research Foundation, 9/1 Vasant Nagar, Nagpur 440022
2.Central India Institute of Medical Sciences,
88/2, Bajaj Nagar, Nagpur 440010 |
|
|
Primary Sponsor
|
| Name |
Lata Medical Research Foundation |
| Address |
9/1, Kinkine Kutir, Vasant Nagar, Nagpur 440022 |
| Type of Sponsor |
Other [Not-for-Profit Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr GM Taori Central India Institute of Medical Sciences |
88/2, Bajaj Nagar, Nagpur 440010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Lothe |
Government Medical College, Nagpur |
Department of Pediatrics, Out Patient Department, GMC, Nagpur, Hanuman Nagar,
Nagpur
MAHARASHTRA |
9730753151
ashishlothe@yahoo.co.in |
| Dr Archana Patel |
Lata Medical Research Foundation |
Research Department,
Lata Medical Research Foundation, 9/1, Kinkine Kutir, Vasant Nagar
Nagpur 440022
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: P369||Bacterial sepsis of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
-Presenting with clinical suspicion/ diagnosis of sepsis
-Seeking care at participating study site i.e. GMCH Nagpur
-Parent/legal guardian willing to provide consent for participation, including sample collection
|
|
| ExclusionCriteria |
| Details |
-Neonates already on antibiotic treatment
-Already enrolled in this or other research study/ clinical trial
-As per clinician judgement precluding any medical condition
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early and accurate detection of pathogen and AMR genotyping towards antimicrobial stewardship in neonatal sepsis |
End of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AMR surveillance by generating crucial data on neonatal sepsis pathogens and resistance patterns in Nagpur, informing local antimicrobial guidelines |
End of the study |
| aid policy development and antimicrobial stewardship program (ASP) implementation in NICUs, ensuring judicious antibiotic use, reducing multidrug-resistant infections, and improving neonatal health outcomes. |
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)
|
10/12/2025 |
| 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="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: Evaluation Of Bacterial Infection and Antimicrobial Stewardship In Neonatal Sepsis from Nagpur District, Maharashtra Using Nanopore Sequencing (MinION), System: A Cross-Sectional Observational Study Population: 100 Indian neonates(<28days) Intervention: None Objectives: 1. To evaluate Nanopore sequencing as rapid identification test for detection of bacterial and fungal infection in whole blood of suspected neonatal sepsis cases (age under 28 days) from GMCH, Nagpur 2. To characterize AMR in these samples towards targeted therapy 3. To evaluate cost- effectiveness of the test. Design/Methodology: This is a cross-sectional observational study, to detect bacterial and fungal infection in whole blood of 100 suspected neonatal sepsis cases & AMR characterization towards targeted therapy by nanopore sequencing. Whole blood samples (total 3 ml- 2 ml blood for routine culture study and an extra 1 ml of research sampling for the sequencing) will be collected from the newborns admitted on suspicion/diagnosis of sepsis at the Government Medical College & Hospital, Nagpur. The blood sample for research will be collected in the same venipuncture done for routine treatment related investigations. There is no intervention involved in this study, so it does not meet the definition of a clinical trial with study arms. Total Duration of Study: Six months |