| CTRI Number |
CTRI/2024/03/063623 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
TO ASSESS THE FINANCIAL IMPACT OF MULTIDRUG RESISTANT ORGANISMS IN ADULT CRITICALLY ILL PATIENTS AT A TERTIARY CARE HOSPITAL |
|
Scientific Title of Study
|
TO ASSESS THE FINANCIAL IMPACT OF MULTIDRUG RESISTANT ORGANISMS IN ADULT CRITICALLY ILL PATIENTS AT A TERTIARY CARE HOSPITAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sr Dr Malti Flawrance MBBS MD IDCCM |
| Designation |
Senior Resident Critical care medicine, SJMCH |
| Affiliation |
St.Johns Medical College Hospital bengaluru |
| Address |
Malti Flawrance, St. Francis Hospital, Beawar Road, Ajmer 305001, Rajasthan.
Malti Flawrance, St. Johns Medical College Hospital
The department of Critical Care Medicine
Bengalore
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414017592 |
| Fax |
|
| Email |
mbundlamsa@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BHUVANA KRISHNA |
| Designation |
PROFESSOR AND HEAD OF THE DEPT, Critical care medicine, SJMCH |
| Affiliation |
St.Johns Medical College Hospital bengaluru |
| Address |
DEPT OF CRITICAL CARE MEDICINE
ST JOHNS MEDICAL COLLEGE HOSPITAL
SARJAPUR ROAD
BENGALURU
DEPT OF CRITICAL CARE MEDICINE
ST JOHNS MEDICAL COLLEGE HOSPITAL
SARJAPUR ROAD
BENGALURU
Bangalore
KARNATAKA
560034
India |
| Phone |
9945693221 |
| Fax |
|
| Email |
bhuvana.11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sr Dr Malti Flawrance MBBS MD IDCCM |
| Designation |
Senior Resident Critical care medicine, SJMCH |
| Affiliation |
St.Johns Medical College Hospital bengaluru |
| Address |
Malti Flawrance, St. Francis Hospital, Beawar Road, Ajmer 305001, Rajasthan.
Dr Bhuvna Krishna
HOD
The Department of Critical Care Medicine
St. Johns Medical College Hospital
Bangalore 34
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414017592 |
| Fax |
|
| Email |
mbundlamsa@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St. Johns Medical College Hospital
Bangalore 34 |
|
|
Primary Sponsor
|
| Name |
Sr Dr Malti Flawrance |
| Address |
St. Johns Medical College Hospital Bengaluru |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sr Dr Malti Flawrance |
St. Johns Medical College Hospital Bengaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sr Dr Malti Flawrance |
St Johns Medical College Hospital |
The Department of Critical care medicine
St Johns Medical College Hospital, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9414017592
mbundlamsa@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-IEC/1/130/2024 |
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, (2) ICD-10 Condition: B956||Staphylococcus aureus as the causeof diseases classified elsewhere, (3) ICD-10 Condition: B961||Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere, (4) ICD-10 Condition: B965||Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere, (5) ICD-10 Condition: B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases- Patients who develop infection with multidrug resistant organisms from the day of admission to discharge from the intensive care unit.
2. Patients above 18years of age
3. Controls- patients admitted to intensive care unit who do not have infection with multidrug resistant organisms
4. Both medical and surgical patients.
|
|
| ExclusionCriteria |
| Details |
Patients with consent for comfort care. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the inpatient cost of intensive care unit stay associated with multidrug-resistant organisms in critically ill adult patients |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
10/03/2024 |
| 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="0"
Months="3"
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
|
As per the World Health Organization (WHO) fact sheet, infections by antimicrobial-resistant organisms can result in failure of treatment, increased cost of medical treatment, increased hospitalization stay and increased socioeconomic burden, there have not been any Indian study substantiating the escalated financial burden and resource utilization. Multiple indirect evidences like increased antibiotics consumption, prolonged length of ICU stay and increased mortality rate have been pointers towards the need for an Indian study which could highlight the magnanimity of the problem. |