CTRI

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CTRI Number

CTRI/2024/03/064568 [Registered on: 20/03/2024] Trial Registered Prospectively

Last Modified On:

21/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Educational]

Study Design

Other

Public Title of Study

Improving how we use antibiotics to treat infections in people with kidney problems

Scientific Title of Study

Optimization of Antimicrobial Therapy in Chronic Kidney Disease Patients with Bacteremia: A Pragmatic 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	Abdullah Yahya Ebrahim Zaawari
Designation	PhD Scholar
Affiliation	Kastruba Medical College Manipal
Address	Department of Microbiology, Kasturba Medical College, Manipal, Karnataka - 576104 Udupi KARNATAKA 576104 India Udupi KARNATAKA 576104 India
Phone	7981287360
Fax
Email	abdullah.kmcmpl2022@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Vandana K E
Designation	Professor and Head
Affiliation	Kasturba Medical College Manipal
Address	Department of Microbiology, Kasturba Medical College, Manipal, Karnataka - 576104 Udupi KARNATAKA 576104 India Udupi KARNATAKA 576104 India
Phone	9902206009
Fax
Email	vandana.ke@manipal.edu

Details of Contact Person
Public Query

Name	Abdullah Yahya Ebrahim Zaawari
Designation	PhD Scholar
Affiliation	Kasturba Medical College Manipal
Address	Department of Microbiology, Kasturba Medical College, Manipal, Karnataka - 576104 Udupi KARNATAKA 576104 India Udupi KARNATAKA 576104 India
Phone	7981287360
Fax
Email	abdullah.kmcmpl2022@learner.manipal.edu

Source of Monetary or Material Support

Manipal Academey of Higher Education

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

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 Abdullah Yahya Ebrahim Zaawari	Kasturba Medical College	Department of Microbiology, 2nd Floor, Basic Sciences building, Kasturba Medical College, Manipal, Karnataka -576104 Udupi KARNATAKA Udupi KARNATAKA	7981287360 abdullah.kmcmpl2022@learner.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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	In this study, we are studying physicians prescribing practice regarding antibiotic use for chronic kidney disease patients with bacteremia

Intervention / Comparator Agent

Type	Name	Details
Intervention	Educational intervention for antimicrobial stewardship	We will identify opportunities for antimicrobial stewardship and advise the doctors on the same. Then we will conduct educational modules emphasizing the importance of antimicrobial stewardship and assess the acceptance of such interventions post educational modules.
Comparator Agent	Pre Intervention	Post intervention will be compared with Pre intervention in term of antimicrobial stewardship practice.

Inclusion Criteria

Age From	19.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Physicians involved in prescribing antibiotics for CKD patients bactermia will be included for this educational intervention study. Nursing staff involved in administration of antibiotics will also be involved.

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
1. Reduction in days of therapy (DOT) 2. Improvement of imperical therpay	we will assess the outcome at baseline (Pre intervention), then at 4 and 8 weeks.

Secondary Outcome

Outcome	TimePoints
To develop strategies to improve and rationalize antibiotics use for CKD patients with bacteremia	We will measure the outcomes at time points 4 weeks & 8 weeks

Target Sample Size

Total Sample Size="366"
Sample Size from India="366"
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="3"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Other (Terminated)

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 CKD patients admitted with bacteremia regardless of the source. 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 and nurses. 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.