| CTRI Number |
CTRI/2022/09/045558 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the prevalence of antibiotic resistance and its treatment in hospital-acquired bloodstream infection cases |
|
Scientific Title of Study
|
Prevalence and Rationale of Treatment of Carbapenem-Resistant Enterobacteriaceae (CRE) in Hospital Acquired Bloodstream Infection in Adult ICUs |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor and Associate Dean |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, 2nd floor, Basic Science building, Madhavnagar, Manipal - 576104, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Ms Isha Mathur |
| Designation |
Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, 2nd floor, Basic Science building, Madhavnagar, Manipal - 576104, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9910158864 |
| Fax |
|
| Email |
isha.mathur@learner.manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Ms Isha Mathur |
| Designation |
Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, 2nd floor, Basic Science building, Madhavnagar, Manipal - 576104, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9910158864 |
| Fax |
|
| Email |
isha.mathur@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Manipal Academy of Higher Education, manipal.edu building, Madhavnagar, Manipal - 576104, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chiranjay Mukhopadhyay |
Kasturba Medical College |
Department of Microbiology, 2nd floor, Basic Sciences building, Manipal Academy of Higher Education, Madhavnagar, Manipal - 576104, Karnataka Udupi KARNATAKA |
9845513057
chiranjay.m@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 |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Patients admitted to ICU with suspicion of infection or with a blood culture positive report
- Follow up records available |
|
| ExclusionCriteria |
| Details |
- Patients discharged against medical advice and or follow up not available
- Adequate blood samples not available for culture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of the prevalence of carbapenem resistance in Enterobacteriaceae. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analysing the patterns of carbapenem resistance in Enterobacteriaceae. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
19/09/2022 |
| 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="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the present ‘post-antibiotic era’, understanding the prevalence of Carbapenem-resistant
GNBs is of utmost importance since it is the first step toward effective antimicrobial
stewardship and prevention and control of infection. Awareness regarding the consequence of
CRE infections resulting in high mortality and morbidity and collating the real-world data are
critical as these help in making evidence-based decisions that may improve clinical outcomes.
Further, this study will help develop an understanding of the socio-economic implications of the increased average length of hospital stay, loss of income and out-of-pocket expenditures. WHO
has also identified Carbapenem-resistant GNBs as critical pathogens, and data from continuous
monitoring is crucial for urgent drug discovery, research and subsequent development
programs. This study will help in understanding the microbiological diagnosis of antibiotic
resistance, comprehending clinical-microbiological correlation and treatment planning with a
very limited arsenal of antibiotics. From this perspective, the study is planned to understand the microbiological nature of bloodstream infections in the laboratory, with a focus on the phenotypic and genotypic determination of
antibiotic resistance and clinical correlation to the treatment outcome.
|