| CTRI Number |
CTRI/2025/04/085773 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Infection by resistant organisms & their Genes in Post Covid Era- An Observational Study in ICU |
|
Scientific Title of Study
|
Epidemiological study of Infection by resistant organisms & their Gene expression in Post Covid Era- An Observational Study in a tertiary center ICU |
| 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 |
Bhawesh Upreti |
| Address |
Department of Critical Care Medicine
Indira Gandhi Institute of Medical Sciences
Patna, Pin 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 |
Room 10 CCM ICU
Department of Critical Care Medicine
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 |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients whose samples were sent for multiplex PCR for Syndromic testing during study period.
|
|
| ExclusionCriteria |
| Details |
Patients < 15 years of age and >90 years of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To record the organisms identified in samples of ICU patients using multiplex PCR along with the resistance genes expressed by them |
At Baseline (On admission) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of carbapenem resistance genes |
At Baseline (On admission) |
| Antibiotics used in those infected with carbapenem resistant organisms |
At Baseline (On admission) |
| 30 days Mortality among those with carbapenem resistance |
At Baseline (On admission) |
| Prevalence of multi colonization |
At Baseline (On admission) |
| Comparison with ICU infections by carbapenem resistant organisms in pre COVID era |
At Baseline (On admission) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/05/2025 |
| 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 Multiplex PCR results of all the
patients included in the study will be noted. The resistant genes expressed by
them will also be documented. The proportion of patient samples showing
carbapenem resistance will be calculated. The proportion of patients with infection
by multiple organisms will also be calculated. The antibiotics used in the
treatment of these patients will be documented. The antibiotic usage and
mortality among those infected with organisms expressing genes for carbapenem
resistance will also be noted. The proportion of patients with organisms showing
Carbapenem resistance (using multiplex PCR in post COVID era patients and the
available culture sensitivity reports of patients admitted in pre COVID era) will
be compared.
|