| CTRI Number |
CTRI/2025/08/092325 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Creating an information-based support system to help nurses give better treatment with antimicrobials. |
|
Scientific Title of Study
|
Development of automated system for decision making in intravenous antimicrobial administration practice |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Jose K J |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher education, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8089944572 |
| Fax |
|
| Email |
akash1.mcopsmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu Upendran |
| Designation |
HOD and Senior Consultant |
| Affiliation |
Lourdes Hospital Post Graduate Institute of Medical Science and Research |
| Address |
Room No 1 Department of Nephrology
Lourdes Hospital Post Graduate Institute of Medical Science and Research, Kochi
Ernakulam
KERALA
682012
India |
| Phone |
9946723829 |
| Fax |
|
| Email |
binupendra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh V |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher education, Manipal |
| Address |
Room No 7, Department of Pharmacy Practice, 4th floor of Manipal College of Dental Science, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9538417313 |
| Fax |
|
| Email |
rajesh.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Akash Jose K J |
| Address |
Room No:02, Department of Pharmacy Practice, St Josephs College of Pharmacy, Dharmagiri College Campus, Naipunnya Road, Cherthala, Kerala 688524 |
| Type of Sponsor |
Other [Self] |
|
|
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 Binu Upendran |
Lourdes |
Room No: 1,Nephrology Department, Lourdes hospital Road Pachalam P O, Kochi, Kerala 682012
Ernakulam
KERALA |
9946723829
binupendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lourdes Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Training Program |
A one-time Intervention will be conducted on the cohort for a duration of one week to assess its impact. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nursing professionals with a minimum of one year of experience in IV Drug Administration.
Nursing professionals who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Professionals currently not involved in IV Drug Administration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Promotion of uniformity in antimicrobial preparation, administration practice, and improve Patient Safety |
24th and 36th months from the date of the study initiation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enhance the knowledge of nurses regarding administration protocols, improve skill in specific areas of antimicrobial administration, reduce administration errors and promote best practice. |
Intervention will be done at a time point of 24th months from the start of the study. |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="4"
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 will identify gaps in knowledge, attitude, and practice among nursing professionals on the administration of intravenous antimicrobial agents and focus on developing an administration practice guideline. Following the development of guidelines, emphasis will be placed on improving nursing care practice, specifically in the administration of intravenous antimicrobials through an intervention and training program. |