| CTRI Number |
CTRI/2021/08/035371 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Secondary infections among Covid 19 patients admitted to ICU |
|
Scientific Title of Study
|
Prevalence and clinical outcomes of secondary infections associated with covid 19 in patients admitted to ICU. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baby Sailaja K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Critical care Unit,
Dept of critical care medicine.
No.1, Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby Sailaja K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Critical care Unit,
Dept of Critical care Medicine
No.1, Ramachandra Nagar, Porur,
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baby Sailaja K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Critical care Unit,
Dept of Critical care Medicine.
No.1, Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research,
No 1, Ramachandra Nagar,Porur, Chennai, 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Baby Sailaja |
Sri Ramachandra Institute of Higher Education and Research |
Critical care unit, Dept of Critical care Medicine
Chennai
TAMIL NADU |
9600159482
sailajaroop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee II, Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients confirmed positive for COVID 19 disease admitted to the ICU |
|
| ExclusionCriteria |
| Details |
patients tested negative for COVID 19 disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of secondary infection and microbiological species |
after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICU mortality rate and ICU length of stay |
After 4weeks |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
16/08/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study. All confirmed cases of COVID 19 patients admitted to ICU will be included in the study. Patient’s general information and medical history will be extracted from the patient’s record and includes age, gender and other co-morbidities. The following data will be collected from the time of ICU admission: Date of ICU admission, temperature, GCS, SOFA and APACHE II score and detailed clinical findings at admission. The investigations, complications developed during the ICU stay and the treatment the patient underwent in ICU will be captured. The primary outcome measured prevalence of secondary infection, source of infection, commonest bacterial and fungal species causing these infections.
The secondary outcome measured - In-ICU mortality, ICU length of stay
|