| CTRI Number |
CTRI/2024/03/063630 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Recommendations provided to improve treatment strategies of CR-Kp] |
| Study Design |
Other |
|
Public Title of Study
|
Developing the strategies of antimicrobial treatment for blood stream infections due to carbapenem resistant klebsiella pneumoniae |
|
Scientific Title of Study
|
Optimizing antimicrobial treatment strategy for Carbapenem resistant Klebsiella pneumoniae bacteremia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Shanbhag |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
ICU-2, Department of Critical Care, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901960496 |
| Fax |
|
| Email |
vishal.shanbhag@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Shanbhag |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
ICU-2, Department of Critical Care, Kasturba Medical College, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
9901960496 |
| Fax |
|
| Email |
vishal.shanbhag@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Shanbhag |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
ICU-2, Department of Critical Care, Kasturba Medical College, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
9901960496 |
| Fax |
|
| Email |
vishal.shanbhag@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Karnataka- 576104, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashikiran Umakanth |
Dr. TMA Pai Hospital, Udupi |
MICU 1,2, Department of General Medicine, Dr. TMA Pai, Udupi- 576101
Udupi
KARNATAKA |
9008418171
shashikiran.u@manipal.edu |
| Dr Vandana KE |
Kasturba Medical College and Kasturba Hospital, Manipal Academy of Higher Education, Manipal |
ICU-1,2,3,Department of critical care, Kasturba Medical College, MAHE, Manipal, Karnataka-576104
Udupi
KARNATAKA |
9902206009
vandana.ke@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional ethics committee |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional ethics committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Developed treatment strategy for Cr-Kp bacteremia |
Personalized antimicrobial treatment strategy will be developed based on an integrated stewardship approach |
| Comparator Agent |
Existing treatment strategy for Cr-Kp bacteremia |
Current treatment of Cr-Kp does not include genotypic analysis of individual patients. Therapy varies from physician to physician purely based on clinical experience. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed with blood stream infections due to carbapenem resistant klebsiella penumoniae anytime during their hospital stay. |
|
| ExclusionCriteria |
| Details |
patients received from outside hospital who had a positive culture for bacteremia after 48 hours, patients with polymicrobial bacteremia, patients with cystic fibrosis, patients who do not have a carbapenem susceptibility test or noninterpretable susceptibility test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The integrated stewardship approach based on evidence-based recommendation will help to develop a standard treatment guideline for difficult to treat CR-Kp infections. |
After obtaining culture positive sample for Cr-Kp |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optimization of appropriate antibiotic regimen based on the genotype of CR-Kp will help in individualized antimicrobial therapy, providing better outcomes of the patient & prevent treatment failure or antimicrobial resistance. |
After obtaining a positive blood culture for Cr-Kp |
| Cost-effectiveness analysis of incorporating PCR techniques in CR-Kp will help in better management of patients in low-middle socioeconomic countries like India. |
Throughout the hospital stay of the patients based on clinical outcomes |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
07/02/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This
will be a multi-centric prospective interventional study that involves developing and applying treatment strategies for CR-Kp concerning clinical outcomes,
carbapenemase genotype, and cost-effectiveness. Treatment strategies will be
developed based on analyzing existing treatment patterns, collected retrospectively and correlating the genotypic pattern with clinical
outcomes of CR-Kp. Focus group discussion will be conducted to finalize the
developed dosing strategies. The effectiveness of the developed treatment strategies
will be studied through an interventional design. Cost-effectiveness analysis
of the developed strategy over the conventional strategies will be evaluated. Outcomes
for safety and efficacy of the developed strategy will be analyzed. Outcomes
from this study would enable the developing of clinical practice guidelines for antimicrobial
therapy of CR-Kp, which would help in optimizing therapy based on genotypic
analysis.
|