| CTRI Number |
CTRI/2023/05/052245 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Survey for detection of superbugs affecting ill patients coming to hospital in emergency. |
|
Scientific Title of Study
|
Screening for Multidrug resistant Organism colonization and associated risk factors among the critically ill patients attending Emergency Department: A targeted surveillance strategy for infection prevention |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ujjwala Gaikwad |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Microbiology
All India Institute of Medical Sciences Raipur
G E Road Tatibandh
Raipur Chhattisgarh
Raipur CHHATTISGARH 492099 India |
| Phone |
8518881724 |
| Fax |
|
| Email |
ujugaikwad@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ujjwala Gaikwad |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Microbiology
All India Institute of Medical Sciences Raipur
G E Road Tatibandh
Raipur Chhattisgarh
Raipur CHHATTISGARH 492099 India |
| Phone |
8518881724 |
| Fax |
|
| Email |
ujugaikwad@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ujjwala Gaikwad |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Microbiology
All India Institute of Medical Sciences Raipur
G E Road Tatibandh
Raipur Chhattisgarh
Raipur CHHATTISGARH 492099 India |
| Phone |
8518881724 |
| Fax |
|
| Email |
ujugaikwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raipur |
| Address |
All India Institute of Medical Sciences
G E Road Tatibandh Raipur
Chhattisgarh |
| Type of Sponsor |
Government medical college |
|
|
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 Ujjwala Gaikwad |
All India Institute of Medical Sciences Raipur |
Emergency ward, ground floor, Trauma and emergency block, AIIMS Raipur, GE Road, Tatibandh, Raipur Raipur CHHATTISGARH |
8518881724
ujugaikwad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z229||Carrier of infectious disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Critically ill patients attending emergency department of AIIMS Raipur for any medical or surgical condition.
2. Patients with previous history of hospitalization of at least 48 hours for any reason and referred to AIIMS Raipur for further care.
3. Patients with history of repeated contact with the health care facilities (irrespective of duration of hospitalization) for various procedures like dialysis, wound management, chemotherapy etc.
4. Patients > 14 years of age
|
|
| ExclusionCriteria |
| Details |
1. Patients having diarrhea
2. Patients not willing to participate in the study
3. Patients coming with shorter emergency observations (like URI, UTI, asthma exacerbation etc.) and not admitted in triage area
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of overall MDRO colonization among new admissions
Proportion of individual MDRO colonization among new admissions
Proportion of individual MDRO colonization among all colonized patients
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of individual risk factor with any MDRO colonization |
1 year |
|
|
Target Sample Size
|
Total Sample Size="521" Sample Size from India="521"
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)
|
01/07/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication out of this trial yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ujugaikwad@gmail.com].
- For how long will this data be available start date provided 21-12-2024 and end date provided 21-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Infections caused by Multi drug resistant Organisms (MDROs) in hospitalized patients are difficult to treat and hence are associated with high morbidity and mortality. Patients with co-morbidities, long standing hospitalization, use of invasive devices and high consumption of broad-spectrum antimicrobial agents are particularly vulnerable to acquire such infections. Development of infection or invasive disease by MDROs is typically preceded by colonization of the patients with these pathogens. In a tertiary care health care facility like AIIMS Raipur, where patients are mostly referred from other hospitals after being hospitalised for a long period of time and being exposed to multiple antimicrobial agents, it is expected that patients arriving are already infected/colonized with MDROs. These patients have the potential to spread MDRO to other non-infected patients, health care workers, and the hospital environment. Such patients, if identified early for the presence of MDRO, followed by isolation (contact precautions) from other patients, will help to reduce the spread of these pathogens. However, due to limited resources to conduct this as a regular activity in a long run, universal screening of all patients admitted to an ICU/ward may not always be feasible. On the contrary, resources can be best utilised to gain the most benefit from this activity if they are targeted to a specific group of patients and the most common MDRO causing colonisation. In light of this, the current study is designed to collect baseline information on the most common MDRO and a group of patients at high risk of colonisation at the time of admission in emergency department of AIIMS Raipur. This type of targeted surveillance can be incorporated into the institute’s routine infection control and prevention activities and can help to control hospital acquired infections caused by emerging MDROs. |