| CTRI Number |
CTRI/2024/04/065714 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Study |
| Study Design |
Other |
|
Public Title of Study
|
Causes of major infections in people with diabetes and kidney diseases from the population, particularly the disease melioidosis, at a large hospital. |
|
Scientific Title of Study
|
Etiology of Community- Acquired Sepsis (CAS) in High Risk Population in a Tertiary Care Hospital with special focus on Melioidosis |
| 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 Smrithy Oliyath Joshi |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, 2nd Floor, Basic Sciences building, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9591413744 |
| Fax |
|
| Email |
rithu57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana KE |
| Designation |
Professor and Head of Department, Department of Microbiology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, 2nd Floor, Basic Sciences building, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9902206009 |
| Fax |
|
| Email |
vandana.ke@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana KE |
| Designation |
Professor and Head of Department, Department of Microbiology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology, 2nd Floor, Basic Sciences building, Kasturba Medical College, Manipal, Udupi
KARNATAKA
576104
India |
| Phone |
9902206009 |
| Fax |
|
| Email |
vandana.ke@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) (Govt Organisation) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
V. Ramalingaswami Bhawan, P.O.Box No. 4911, Ansari Nagar, New Delhi, India -110029
|
| Type of Sponsor |
Government funding agency |
|
|
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 Smrithy Oliyath Joshi |
Kasturba Medical College and Hospital |
Departments of Microbiology, Medicine, Critical Care, Emergency Medicine and Nephrology, kasturba Medical College and Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9591413744
rithu57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients hospitalized with clinical diagnosis of community-acquired sepsis (CAS), along with previously or newly diagnosed diabetes mellitus and/or chronic kidney diseases will be included in the study. |
|
| ExclusionCriteria |
| Details |
Pediatric patients, pregnant women, and patients who do not give consent to do the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help in:
• Understanding the microbial pathogens associated with community acquired sepsis in high risk patients and the prevalence of melioidosis in these patients.
• Understanding the antimicrobial susceptibility of the implicating pathogens in the study population which will guide treatment.
|
Assessment will be done at baseline, 4 weeks, and 8 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identify the risk factors and various patterns of clinical presentations and antimicrobial susceptibility pattern of melioidosis in our patient population which will help clinicians and microbiologists to have a broader view of the whole disease and to keep up a high index of suspicion while dealing with patients, which is very essential in diagnosis and treatment of this condition.
|
Assessment will be done at baseline, 4 weeks, and 8 weeks.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/05/2024 |
| 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 Applicable |
| 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
|
The primary objectives of this study are to understand the microbial etiology of community-acquired sepsis in patients with diabetes and/or chronic kidney disease admitted to Kasturba Medical College and Kasturba Hospital, Manipal and to study the prevalence of melioidosis in the above population. The secondary objective is to characterize the phenotypic and genotypic resistance of B.pseudomallei, the causative agent of melioidosis
|