| CTRI Number |
CTRI/2025/01/079218 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hospital acquired infections & Terminal Disinfection in a Dormitory like ICU: An observational study |
|
Scientific Title of Study
|
Correlation of Hospital acquired infections & frequency of Terminal Environmental Disinfection in a Dormitory like ICU: An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawesh Upreti |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences Patna |
| Address |
Department of Critical Care Medicine
Indira Gandhi Institute of Medical Sciences Patna
Patna
BIHAR
800014
India |
| Phone |
9756114748 |
| Fax |
|
| Email |
bhaweshupreti802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhawesh Upreti |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences Patna |
| Address |
Department of Critical Care Medicine
Indira Gandhi Institute of Medical Sciences Patna
Patna
BIHAR
800014
India |
| Phone |
9756114748 |
| Fax |
|
| Email |
bhaweshupreti802@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawesh Upreti |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences Patna |
| Address |
Department of Critical Care Medicine
Indira Gandhi Institute of Medical Sciences Patna
Patna
BIHAR
800014
India |
| Phone |
9756114748 |
| Fax |
|
| Email |
bhaweshupreti802@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences Patna Pin 800014 Bihar India |
|
|
Primary Sponsor
|
| Name |
Dr Bhawesh Upreti |
| Address |
Department of Critical Care Medicine
Indira Gandhi Institute of Medical Sciences Patna 800014 Bihar India |
| Type of Sponsor |
Other [Self] |
|
|
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 Ritu Singh |
Indira Gandhi Institute of Medical Sciences Patna |
Department of Critical Care Medicine
Indira Gandhi Institute of Medical Sciences Patna
Patna
BIHAR |
8127395753
ritusingh140@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Indira Gandhi Institute of Medical Sciences Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1- Patients admitted in CCM ICU whose samples were sent or will be sent for culture & sensitivity (after 1st 48 hours of admission) since April 2022 till April 2025
2- Patients with age more than 10 years and less than 95 years are included
|
|
| ExclusionCriteria |
| Details |
1- The samples sent within first 48 hours of admission of patient to CCM ICU will be excluded
2- Pediatric patients who are pre adolescent are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the correlation between hospital acquired infections identified in samples of ICU patients & frequency of Terminal Environmental Disinfection done in ICU. |
April 2022 to April 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To record adverse effects of Terminal Environmental Disinfection. |
April 2022 to April 2025 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Culture and sensitivity reports
(blood, urine, sputum, ET aspirates etc.) of all the patients admitted in CCM
ICU will be followed. The samples sent in first 48 hours of patient admission
will be excluded. The date of terminal environmental disinfection done in ICU will
be noted. The period between two such disinfections will be divided into 10 days
periods. The proportion of positive culture samples in each 10 days periodwill
be noted.The proportion of positive cultures in various 10 days periods will be
compared. It would be observed whether doing terminal environmental
disinfection has any impact on proportion of positive culture samples. It will
be observed that whether there is any increase in proportion of positive
culture sample as we move away from the date of terminal environmental
disinfection (& if that’s the case then what should be the ideal
time/frequency of terminal environmental disinfection). |