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CTRI Number  CTRI/2025/03/081532 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Methodological strategies to improve antimicrobial prescription]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Improving Antibiotic Use in Indian Hospitals: Developing and Testing Strategies for Better Healthcare 
Scientific Title of Study   Development and Evaluation of Methodological Strategies for Implementation of Antimicrobial Stewardship in Secondary Care Hospitals in Indian Setting: A Design Science Approach 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajalakshmi R 
Designation  Research Scholar 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8089501101  
Fax    
Email  rajalakshmi.mcopsmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Girish Thunga 
Designation  Associate Professor 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Girish Thunga 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Centre for Toxicovigilance and Drug Safety 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Kamath  Dr N R Acharya Memorial Hospital  N.H-66, Koteshwara Kundapura Taluk, Udupi District Pin - 576 222
Udupi
KARNATAKA 		 9844091370

drnramh83@yahoo.com  
Dr Vajid N V  IQRAA International Hospital and Research Centre  Wayanad Rd, Malaparamba, Kozhikode, Kerala 673009
Kozhikode
KERALA 		 9605555029

vajidnv@gmail.com 
Pundarika Holla  Mitra Hospital  Old Post Office Road, Udupi 576 101
Udupi
KARNATAKA 		 9880261601

mitra@mitrahospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  The intervention involves developing, implementing, and evaluating a tailored antimicrobial stewardship (AMS) program in secondary care hospitals in India through a phased approach of scoping reviews, quality improvement planning, and pilot implementation with stakeholder engagement and continuous evaluation.  The intervention aims to implement an Antimicrobial Stewardship (AMS) program in secondary care hospitals through a phased approach. In Phase 1, a scoping review will identify barriers, facilitators, and prescriber perceptions related to AMS, complemented by a point prevalence survey (PPS) to assess antimicrobial consumption patterns. This phase also includes data collection on hospital infrastructure and staff training, followed by stakeholder interviews to explore current antibiotic practices and constraints. In Phase 2, a Quality Improvement Plan (QIP) will be developed based on stakeholder needs and expert recommendations, incorporating the establishment of AMS teams, prescribing guidelines, audits, feedback mechanisms, and infection control enhancements. The plan will undergo rigorous validation through expert reviews, surveys, and Delphi methodology to ensure its reliability and applicability. Phase 3 involves piloting and evaluating the QIP in selected hospitals, with stakeholder feedback and training, to optimize AMS practices. Over an 8-month follow-up period, the intervention’s effectiveness will be assessed by tracking antibiotic usage and adherence to AMS recommendations. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Phase 1
Identification and selection of secondary care hospitals

i. Hospitals having bed capacity typically ranging from 50-500 beds, and willing to participate in
the study and collaborate with the research team
ii. Hospitals located within the district to ensure accessibility for site visits and ongoing support
iii. Hospitals having basic infrastructure and resources to support data collection and without a pre-existing AMS program
iv. Availability of key stakeholders (e.g., hospital administration, medical staff) who are willing to
engage in the study and provide necessary information
v. Hospitals that agree to participate in the study following ethical approval from relevant ethics
committees or institutional review board

Point Prevalence survey
i. Patients more than 18 years of age admitted in the clinical settings before 8 am on the study
day
ii. Patients prescribed with at least one systemic/oral antibiotic

Phase 2
Qualitative Interview with the physician

i. Physicians who are currently practicing in the selected clinical settings with more than 3 years
of experience
ii. Physicians with consent to participate in the study and willing to share their experiences and
perspectives
iii. Physicians available for the duration of the study and able to commit the necessary time for the
interview  
 
ExclusionCriteria 
Details  Phase 1
Identification and selection of secondary care hospitals

i. Hospitals that do not consent to participate or show lack of interest in the study
ii. Hospitals with fewer than 50 beds or more than 500 beds, thus not fitting the secondary care
designation based on bed capacity
iii. Hospitals with a well-established AMS program that do not require support or improvement in
this area

Point Prevalence survey
i. Patients admitted after 8 am in the morning on data collection day
ii. Patient in outpatient and emergency departments
iii. Patients intended to be discharged on the day of survey
iv. Patients posted for surgery on the day of the survey

Phase 2 Qualitative interview with the physicians
i. Physicians with fewer than the required minimum years of clinical practice (less than 3 years)
ii. Physicians who do not consent to participate in the study or are unwilling to share their
experiences and perspectives
iii. Physicians who cannot commit the necessary time for the interview and any follow-up due to
their schedule
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in inappropriate antimicrobial use, measured by compliance with Antimicrobial Stewardship (AMS) program recommendations and hospital-specific prescribing guidelines.  Baseline, mid-implementation (4 months), and end of follow-up (8 months). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage adherence to local antibiotic prescribing guidelines.
2. Improvement in AMS knowledge scores from pre-training to post-training.
3. Proportion of prescriptions identified as inappropriate based on AMS criteria.
4. Changes in healthcare-associated infection rates. 		 Assessed at baseline and at the end of the follow-up period (8 months). 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   28/03/2025 
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 Yet Recruiting 
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 project, titled Development and Evaluation of Methodological Strategies for Implementation of Antimicrobial Stewardship in Secondary Care Hospitals in the Indian Setting: A Design Science Approach, aims to improve antimicrobial stewardship (AMS) practices in secondary care hospitals across India. Its primary objective is to design, implement, and evaluate a comprehensive quality improvement plan (QIP) to address barriers to effective AMS, optimize antimicrobial usage, and enhance infection control practices. This project focuses on real-world applicability, especially in resource-constrained healthcare settings.

In Phase 1, the preparatory phase, a scoping review will identify barriers, facilitators, prescriber perceptions, and gaps in existing AMS programs in secondary care hospitals. Comprehensive data collection will assess the infrastructure, staffing, and key performance indicators of hospitals. A point prevalence survey (PPS) will analyze patterns of antimicrobial consumption and prescribing practices, supported by pilot testing and training for hospital coordinators. Stakeholder interviews will further explore the challenges in implementing AMS programs, assess prescriber awareness, and evaluate institutional support. Hospitals will then be categorized using stratified random sampling and simple randomization to ensure regional representation. The data collected will guide the subsequent development of the QIP.

In Phase 2, a tailored QIP will be designed based on stakeholder needs and expert recommendations. This plan will include forming dedicated AMS teams, appointing AMS champions, establishing prescribing guidelines, enhancing infection control measures, and integrating point-of-care testing. Robust documentation protocols, continuous audits, and feedback mechanisms will also be implemented. The QIP will undergo rigorous validation through expert panel reviews, focus group discussions, and iterative refinement using the Delphi methodology. Its content validity will be assessed using the Content Validity Index (CVI), and qualitative analysis will generate actionable themes to improve reliability and applicability.

In Phase 3, the validated QIP will be piloted and implemented in selected hospitals. Secondary care stakeholders will participate in discussions to refine the final plan and address potential implementation challenges. Structured mentorship and comprehensive training will be provided to AMS teams to facilitate effective execution. Baseline data collection and interim evaluations will help optimize the intervention throughout the implementation period. Over an 8-month follow-up, the effectiveness of AMS interventions will be assessed through primary and secondary outcomes, including reduced antimicrobial consumption (measured as DDD per 1,000 patient-days), improved compliance with AMS recommendations, enhanced healthcare professional knowledge, reduced inappropriate prescriptions, and improved infection control metrics.

This project has significant implications for addressing antimicrobial resistance (AMR) in India. By developing an evidence-based, scalable QIP, it aims to improve prescribing practices, enhance infection control, and reduce AMR in secondary care hospitals. The findings could serve as a model for AMS implementation in similar resource-limited settings globally, contributing to improved public health outcomes.

 
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