| CTRI Number |
CTRI/2025/01/079135 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating and Assessing students Knowledge, Attitude, and Practices regarding antibiotic resistance and use among unversity students using validated questionnaire |
|
Scientific Title of Study
|
Development and validation of survey questionnaire to assess the KAP on antimicrobial use and resistance among medical and non-medical students in a University. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi Upadhya K |
| Designation |
MSc Medical Laboratory Technology (Microbiology and Immunology) |
| Affiliation |
Manipal College of Health Professions(MCHP), MAHE. |
| Address |
Department of Medical Laboratory Technology, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7022340998 |
| Fax |
|
| Email |
swathi.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Aneena Varghese |
| Designation |
Assistant Professor “ Selection Grade" |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Laboratory Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9526787947 |
| Fax |
|
| Email |
aneena.varghese@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aneena Varghese |
| Designation |
Assistant Professor “ Selection Grade" |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Laboratory Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9526787947 |
| Fax |
|
| Email |
aneena.varghese@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Reshma Maria Cocess Dsouza |
Manipal Academy of Higher Education |
Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104.
Udupi
KARNATAKA |
8147804182
reshma.dsouza@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(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students who are willing to participate |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All genders
Graduates belonging to Manipal Academy of Higher Education |
|
| ExclusionCriteria |
| Details |
Graduates who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prepare and validate questionnaire on KAP on antimicrobial use and resistance among medical and non-medical students in a university |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the KAP score on antimicrobial use & resistance among medical & non-medical students in a university.
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="1066"
Sample Size from India="1066"
Final Enrollment numbers achieved (Total)= "601"
Final Enrollment numbers achieved (India)="601" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| 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
|
Participants will be recruited from various institutions within the Manipal College of Higher Education, encompassing both medical and non-medical fields. An online, validated Knowledge, Attitude, and Practice (KAP) questionnaire will be circulated among eligible students. Prior to questionnaire administration, students will be approached during their lunch breaks or after college hours and provided with an informed consent form. Only those who voluntarily agree to participate after reviewing and giving their consent form will be included in the study. |