| CTRI Number |
CTRI/2024/03/064698 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention about appropriate antimicrobial prescription practice] |
| Study Design |
Other |
|
Public Title of Study
|
To improve the quality of antibiotics usage in the treatment of blood infection |
|
Scientific Title of Study
|
Rationalizing Antibiotic Treatment for Enterobacterales bactermemia of urinary source: A quality improvement 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 |
Dr Vandana K E |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9902206009 |
| Fax |
|
| Email |
vandana.ke@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana K E |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9902206009 |
| Fax |
|
| Email |
vandana.ke@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana K E |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9902206009 |
| Fax |
|
| Email |
vandana.ke@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Microbiology, Kasturba Medical College, Manipal, Karnataka -576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Vandana K E |
Kasturba Medical College |
Department of Microbiology, Room No. 1, 2nd Floor, Basic Sciences building, Kasturba Medical College, Manipal, Karnataka -576104
Udupi
KARNATAKA |
9902206009
vandana.ke@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
In this study, we are studying physicians prescribing practice regarding antibiotic use for patients with Enterobacterales bacteremia of urinary source. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Days of therapy before intervention |
The days of therapy will be measured before and after the educational intervention |
| Intervention |
Educational |
Doctors will be provided with educational sessions on antimicrobial stewardship practices |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Physicians involved in prescribing antibiotics for patients with Enterobacterales bacteremia of urinary source will be included for this educational intervention study. |
|
| ExclusionCriteria |
| Details |
Physicians who are not involved in prescribing antibiotics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in days of therapy (DOT) before and after the educational intervention |
Quarterly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop strategies to improve & rationalize antibiotics use for patients with bacterial infections. |
We will measure the outcomes at time points 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/04/2024 |
| 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="1"
Months="6"
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
|
Firstly, we will conduct a retrospective case record based analysis of patients admitted with bacteremia caused by Enterobacteriales arising from urinary source infection. The information on antimicrobial use and the patient outcome will be gathered.
Based on the information obtained, we will plan an educational module on appropriate choice of antimicrobial therapy in the treatment of condition under our study focus. The educational interactive sessions will be delivered to the physicians. We will use the information gathered in the retrospective data analysis in our presentations.
After the educational intervention, we will measure the appropriateness of antimicrobial therapy and duration in the treatment of condition under our study focus prospectively
|