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CTRI Number  CTRI/2024/12/078365 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding what people in Nagaland know and do about antibiotic use and resistance: A survey study 
Scientific Title of Study   Assessing public knowledge, practice, and attitude of Antibiotic use and Antibiotic resistance in Nagaland: A cross - sectional study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Toshimenla I Jamir 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Healthcare and Hospital Management, No division room no LH 3, Tiger circle Road, Madhav Nagar, Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  8114745278  
Fax    
Email  toshimenla.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Swathi KS 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Healthcare and Hospital Management, Room no-56 Tiger circle Road, Madhav Nagar, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Swathi KS 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Healthcare and Hospital Management, Room no-56 Tiger circle Road, Madhav Nagar, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Source of Monetary or Material Support  
Department of Healthcare and Hospital Management, No division room no LH 3, Tiger circle Road, Madhav Nagar, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Toshimenla I Jamir 
Address  Department of Healthcare and Hospital Management, No division room no LH 3, Tiger circle Road, Madhav Nagar, Manipal, Karnataka, India, 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swathi KS  Prasanna School of Public Health  Department of Healthcare and Hospital Management, no division Room no-56 Tiger circle Road, Madhav Nagar Manipal, Karnataka, India, 576104
Udupi
KARNATAKA 		 9481749911

swathi.ks@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Awareness and knowledge on antibiotic use and resistance 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The study includes all the Individual aged 18 years and above who are resident of
Nagaland. Those who can read and comprehend English will be invited to participate.  
 
ExclusionCriteria 
Details  Individual below 18 years, non- resident of Nagaland, healthcare professional.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will assess the participant knowledge, practice, attitude (KPA) about antibiotic use and resistance
and identify the association between KPA and demographic factors. 		 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
There are no specific secondary outcomes as this is an observational study focusing on assessing knowledge, practice and attitude of antibiotic use and antibiotic resistance.  8 weeks 
 
Target Sample Size   Total Sample Size="424"
Sample Size from India="424" 
Final Enrollment numbers achieved (Total)= "430"
Final Enrollment numbers achieved (India)="430" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/12/2024 
Date of Study Completion (India) 28/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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   Aim- The study aims to understand the Knowledge, Practice, Attitude of Antibiotic use and Antibiotic resistance in Nagaland. Objectives- I. To assess the current knowledge, practice, and attitude of antibiotic usage. II. To analyze the current knowledge of antibiotic resistance. III. To examine the association between sociodemographic characteristics and antibiotic usage.
Justification: Antibiotic resistance is a significant global and national health concern, with India being one of the greatest consumers of antibiotics, resulting in widespread misuse and resistance. However, there is lack of research conducted on the public knowledge, practice, and attitude (KPA) on antibiotic use in Nagaland. This study seeks to address this gap by offering regionally specific insights into how cultural norms and socioeconomic factors influence antibiotic use. The findings will help to design effective public health interventions and surveillance systems, thereby improving health outcomes and aiding national efforts to fight antibiotic resistance. 
Detailed procedure: A cross-sectional quantitative study to collect information regarding knowledge, practice, attitude of antibiotic use and antibiotic resistance will be conducted. Before beginning the study, ethical approval will be taken from Institutional Review Committee (IRC) and Institutional Ethics Committee (IEC). The study will be conducted on the general population of Nagaland which includes adults aged 18 and above. The study will exclude individuals who are not the residents of Nagaland and healthcare professionals. The study will utilize a convenience sampling technique. The data will be collected through structured questionnaire created using google forms that would be distributed through primary and secondary contacts, direct outreach will be through email, WhatsApp, and social media. To increase the survey outreach secondary distribution will make use of already existing network and recommendations. It will be conducted in English, consisting of sociodemographic details and particulars using construct comprising of 8,8,8,7 statements that asses the knowledge, attitudes, practices of antibiotic use and antibiotic resistance. The response will be measured using a 5-point Likert scale. 
 
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