| CTRI Number |
CTRI/2024/10/075538 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
A microbiological study of gram negative bacteria causing infection in blood to patients admitted to intensive care unit |
|
Scientific Title of Study
|
Microbiological profile of gram negative bacteraemia in intensive care unit in a tertiary care hospital, a prospective 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 |
Manojkumar |
| Designation |
Postgraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Registration |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
6380228061 |
| Fax |
|
| Email |
manoojkumaresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Velumuragn selvam |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9968859560 |
| Fax |
|
| Email |
dr.velsri86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head Of Department |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education Research, Porur, Chennai 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 |
| Manojkumar |
Sri Ramachandra Institute Of Higher Education and Research |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU |
6380228061
manoojkumaresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to adult multidisciplinary Intensive care unit.
|
|
| ExclusionCriteria |
| Details |
Patients of age group of less than 18 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the microbiology and resistance of gram negative bacteraemia in intensive care unit and evaluate their outcomes |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality of patient secondary to bloodstream infection |
six months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/12/2024 |
| 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="0"
Months="6"
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
|
Blood stream infections (BSI) are the major cause of morbidity and mortality among patients admitted in Intensive Care Unit. Surveillance of etiological agents in these infections are important for their prevention and treatment. Blood stream infection is the infection that required one or more cultures positive for a bacteria or fungus of blood samples obtained in the presence of fever. The increasing prevalence of antimicrobial resistance (AMR) encountered both in the hospital, generally and in the ICU, specifically, further complicates the care of patients with bloodstream infections. As the prescription of timely and in vitro active antibiotic therapy is a central determinant of outcomes in blood stream infections, growing rates of antimicrobial resistance (AMR) make it difficult for clinicians to ensure that those with blood stream infections receive initially appropriate antimicrobial therapy. |