| CTRI Number |
CTRI/2024/05/067230 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of details of the use of antimicrobial agents and its adherence to institutes antibiotic policy. |
|
Scientific Title of Study
|
A cross sectional study for estimation of adherence to the institutional antibiotic policy in level III neonatal intensive care unit, Pune, India |
| 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 Shuktika Mishra |
| Designation |
JR-1 MD Pharmacology |
| Affiliation |
Bharati Vidyapeeth medical college and Hospital,Pune |
| Address |
Dept.of Pharmacology,Bharati ViDyapeeth deemed to be university Medical College, Maharashtra Pune 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
7378628340 |
| Fax |
|
| Email |
shuktika.mishra-mcp@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Suryawanshi |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth medical college and Hospital,Pune |
| Address |
Dept.of Pharmacology,
1st Floor Medical college
Bharati ViDyapeeth deemed to be university Medical College, Maharashtra Pune 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9403581114 |
| Fax |
|
| Email |
suryawanshi.sonali@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Suryawanshi |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth medical college and Hospital,Pune |
| Address |
Dept.of Pharmacology,
1st Floor Medical college
Bharati ViDyapeeth deemed to be university Medical College, Maharashtra Pune 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9403581114 |
| Fax |
|
| Email |
suryawanshi.sonali@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth medical college and Hospit |
| Address |
Bharati Vidyapeeth medical college and Hospital,Pune |
| Type of Sponsor |
Private 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 Shuktika Mishra |
Bharati Vidyapeeth Deemed To Be University |
Neonatal Intensive care unit 1st floor
Bharati Vidyapeeth Hospital,Pune
Pune
MAHARASHTRA |
7378628340
shuktika.mishra-mcp@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee DCGI ECR 518 |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
The neonates will eligible to be enrolled in the study if admitted in NICU who will be given one or more antibiotic |
|
| ExclusionCriteria |
| Details |
The neonates will be excluded from the study if on treatment other than antibiotics
or who will get discharge or decease within 24 hours from admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine percentage of neonates receiving antibiotic treatment who comply with the Institution’s antibiotic policy. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To ascertain the outcome of neonates treated with antibiotics.
2.To assess proportion of neonates adhering to institutional antibiotic guidelines for Escalation / De-escalation / change of antibiotics
|
1 Year |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Antimicrobials are the most often used classes of medicines in the Neonatal Intensive Care Unit (NICU) with more than 80% of all NICU patients get antibiotics during their hospital stay.WHO identified antibiotic resistance as a persistent danger to public health - made significant changes to the essential medications list, categorizing antibiotics into three categories- aware (access, watch, and reserve) to ensure their availability and proper use.Infection is very common and so is the use of AMAs. Antimicrobial Resistance (AMR)has developed as a result of the complexity and difficulty of treating neonatal sepsis, which has triggered increase use of antibiotics, particularly broader spectrum antibiotics resulted in rise in Antimicrobial Resistance. These difficulties are persistent and more pervasive, according to a more recent systematic review from 2019 on AMR in newborn sepsis in South Asia .It is of paramount importance to use the available AMAs with utmost care. As a result, it will be worthwhile to perform a present study to capture the details of the use of AMAs and to verify its rationality in this institute’s Medical NICU. |