| CTRI Number |
CTRI/2024/02/062204 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
Difficulties Encountered in Promoting Responsible Use of Antibiotics at a Hospital |
|
Scientific Title of Study
|
Challenges Facing in the Implementation of Antimicrobial Stewardship in a Tertiary Care Hospital |
| 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 Yogendra Shrestha |
| Designation |
Associate Professor |
| Affiliation |
Seven Hills College of Pharmacy (Autonomus) |
| Address |
Department of Pharmacy Practice, Venkatramapuram, Tirupati
Chittoor
ANDHRA PRADESH
517561
India |
| Phone |
7348944358 |
| Fax |
|
| Email |
dryogendrastha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkatawari Lavanya |
| Designation |
Student |
| Affiliation |
Seven Hills College of Pharmacy (Autonomus) |
| Address |
Department of Pharmacy Practice, Venkatramapuram, Tirupati
Chittoor
ANDHRA PRADESH
517561
India |
| Phone |
9391798565 |
| Fax |
|
| Email |
lavanyavenkatawari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vavitikalava Sai Sreekar |
| Designation |
Student |
| Affiliation |
Seven Hills College of Pharmacy (Autonomus) |
| Address |
Department of Pharmacy Practice, Venkatramapuram, Tirupati
Chittoor
ANDHRA PRADESH
517561
India |
| Phone |
7337280430 |
| Fax |
|
| Email |
sreekaryadavsai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seven Hills College of Pharmacy |
|
|
Primary Sponsor
|
| Name |
Seven Hills College of Pharmacy |
| Address |
Venkatramapuram, Tirupati |
| Type of Sponsor |
Research institution |
|
|
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 Yogendra Shrestha |
Sri Venkateswara Institute of Medical Sciences |
Department of Pharmacy Practice, Seven Hills College of Pharmacy (Autonomous), Tirupati
Chittoor
ANDHRA PRADESH |
7348944358
dryogendrastha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences, Tirumala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health Care Professional |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults of age above 20 years old.
2. The study includes the treating physician and pharmacist.
|
|
| ExclusionCriteria |
| Details |
1. The participants age of below 20 years old.
2. Mental illness, duf and dum participants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study can identify factors affecting the implementation of Antimicrobial stewardship in the hospital. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study can help to form a new policy considering factors affecting the implementation of Antimicrobial Stewardship. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2024 |
| 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="0"
Months="3"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Antimicrobial resistance (AMR) is a critical threat to public health around the world, and it is becoming more prevalent. India is the nation that uses the most antibiotics globally and has the highest incidences of infectious diseases. The scoping report on antimicrobial resistance in India indicated that more than 70% of the isolates of Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii, and almost half of all Pseudomonas aeruginosa, were resistant to fluoroquinolones and third generation cephalosporins. The emergence of resistance in India has been attributed in important part to the unregulated over-the-counter availability of antibiotics and non-compliance with the recommended treatment duration. The other possible reasons for the emergence of resistant pathogens are antibiotic misuse, overuse, and self-medication. Antibiotic overuse in India has been reported by various studies. |