| CTRI Number |
CTRI/2022/10/046153 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of bacterial correlation in patients and ICU environment at AIIMS Rishikesh |
|
Scientific Title of Study
|
A Comparative study of drug resistance in bacterial isolates from environmental sources and patients with special reference to Critical Care Unit at AIIMS Rishikesh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Agarwal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anesthesia and Critical Care AIIMS Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
|
| Fax |
|
| Email |
ankit.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Ankit Agarwal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anesthesia and Critical Care AIIMS Rishikesh
UTTARANCHAL 249203 India |
| Phone |
|
| Fax |
|
| Email |
ankit.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Ankit Agarwal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anesthesia and Critical Care AIIMS Rishikesh
UTTARANCHAL 249203 India |
| Phone |
|
| Fax |
|
| Email |
ankit.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Uttarakhand State Council for Science and Technology |
|
|
Primary Sponsor
|
| Name |
Uttarakhand State Council for Science and Technology UCOST |
| Address |
Vigyan Dham Jhajra Dehradun Uttarakhand Pin 248007 |
| 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 |
| Ankit Agarwal |
Critical Care Unit AIIMS Rishikesh |
Department of Anesthesia and Critical Care AIIMS Rishikesh Dehradun UTTARANCHAL |
8475000280
ankit.anaes@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All ICU patients with microbiological evidence of infection after 48 hours of admission to ICU
All staff working in the ICU |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Drug resistant bacteria isolated |
48 hours of ICU admission minimum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antibiotic sensitivity pattern |
Within 72 hours of microbial growth |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
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)
|
15/10/2022 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Publication
- For how long will this data be available start date provided 30-09-2024 and end date provided 31-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An ICU has the most seriously ill patients of the hospital. Often the patients are infected with various bacteria. The routine culture sensitivity reporting requires a minimum time interval of 48-72 hours. The patients are so critical that it is not possible to wait for the microbial culture reports and empirical therapy has to be started as early as possible. The microbial population of ICUs is usually different from other areas of the hospital and usually much more resistant as compared to other areas of the hospital. Also many opportunistic pathogens may be present in an ICU Setting. They may be present on equipment being used, other patients, medical and paramedical staff attending them and the surrounding environment of the ICU. Patients in ICU are more susceptible to infections caused by opportunistic pathogens as they have low body resistance due to various underlying diseases, duration of stay in ICU, use of invasive devices like ventilator or catheters etc., immune suppression or disrupted physiological barriers. These opportunistic bacteria are often resistant to most of the antibiotics due to extreme selective pressure in ICU, making them a highly dangerous source of infection for susceptible patients. Since the susceptibility pattern of bacteria differ from place to place and since the prevalence of predominant microorganisms also varies, the pathogens prevalent in a particular setting along with their susceptibility patterns must be known in order to formulate rationale prescribing of antimicrobials. Primary Objective – Since drug resistant opportunistic pathogen are present in the environment of the ICU as well as they are carried by the medical and paramedical staff, an attempt will be made to isolate them from the environment and hands of the medical staff and also from infected patients whose cultures are routinely sent and will be maintained as stock culture to see if a correlation exists between the two. Secondary Objective – Their drug susceptibility pattern will also be studied to find out suitable antibiotic to be started empirically before the culture and sensitivity report is available. |