| CTRI Number |
CTRI/2022/09/045544 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation Of Common Intensive Care Unit Infections In An Indian ICU |
|
Scientific Title of Study
|
Evaluation of Epidemiology and Resistance Patterns Of Intensive Care Unit Infections : A single Centred Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piyush Dhawad |
| Designation |
DrNB critical care medicine Trainee |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
8983248382 |
| Fax |
02066455628 |
| Email |
drpiyushdhawad297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Gurav |
| Designation |
Consultant Neuro Trauma Unit |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
9860034778 |
| Fax |
02066455628 |
| Email |
kirtisushgurav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Gurav |
| Designation |
Consultant Neuro Trauma Unit |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor
40 Sassoon Road Pune 411001
MAHARASHTRA
411001
India |
| Phone |
9860034778 |
| Fax |
02066455628 |
| Email |
kirtisushgurav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Grant Medical Foundation Ruby Hall Clinic NTU2 main building 2nd floor 40 Sassoon road Pune 411001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Students Thesis Topic] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Piyush Dhawad |
Grant Medical Foundation Ruby Hall Clinic |
Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor 40 Sassoon Road Pune 411001
Pune
MAHARASHTRA |
8983248382
02066455628
drpiyushdhawad297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ICU stay ≥48 h and having any one of the infections – VAP Ventilator Associated Pneumonia
Catheter Associated Urinary Tract Infection
Central Line Related Blood Stream Infection CRBSI. |
|
| ExclusionCriteria |
| Details |
Patients aged <18 years of age
Index ICU stay < 48 hours
Re admissions to the ICU within the same hospitalisation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation Of Incidence Of ICU acquired Infections at our Tertiary care critical care department |
If culture positive then till shift out from ICU or Death of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the morbidity and mortality associated with these ICU acquired Infections |
If culture positive then till shift out from ICU or Discharge of patient |
|
|
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)
|
22/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/09/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Incidence of nosocomal infections in the
Intensive Care Unit (ICU) has
been reported to be higher than in general
inpatient hospital population.
Most published studies regarding
epidemiology, microbiology of ICU-
acquired infections such as ventilator associated pneumonia
(VAP),
catheter associated urinary tract
infections (CAUTI) and catheter related
bloodstream infections (CRBSI) have come from industrialized western
countries.
Variations in the incidence, microbiology, and
resistance patterns in Indian ICU’s are not well understood yet. There is limited literature
regarding ICU infections in the Indian setting, and hence, western
guidelines are being extrapolated for the management of these
infections. Till date we don’t have any robust data to formulate our own
Antibiotic stewardship programme.
Hence, we sought to perform this single
centred, epidemiological
prospective study which included evaluating
the epidemiology and
resistance patterns of above mentioned ICU
infections at our centre |