| CTRI Number |
CTRI/2014/03/004441 [Registered on: 03/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A prospective observational study to evaluate the prescribing pattern and microbial sensitivity of antimicrobial agents in Gram-negative severe sepsis/septic shock patients in medical intensive care unit at tertiary care hospital. |
|
Scientific Title of Study
|
A prospective observational study to evaluate the prescribing pattern and microbial sensitivity of antimicrobial agents in Gram-negative severe sepsis/septic shock patients in medical intensive care unit at tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr YP Singh |
| Designation |
HoD-Critical Care |
| Affiliation |
Max Super Specialty Hospital, Patparganj, Delhi |
| Address |
Max Super Speciality Hospital
(A Unit of Balaji Medical and Diagnostic Research Centre)
108A, Indraprastha Extension, Patparganj
New Delhi
DELHI
110092
India |
| Phone |
|
| Fax |
|
| Email |
yogendra.singh2@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SURABHI BHATNAGAR |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Specialty Hospital, Patparganj, Delhi |
| Address |
Max Super Speciality Hospital
(A Unit of Balaji Medical and Diagnostic Research Centre)
108A, Indraprastha Extension, Patparganj
New Delhi
DELHI
110092
India |
| Phone |
|
| Fax |
|
| Email |
bhatnagarsurabhi44@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surabhi Bhatnagar |
| Designation |
M.Pharmacy Student |
| Affiliation |
National Institute of Pharmaceutical Education & Research, Hajipur |
| Address |
National Institute of Pharmaceutical Education and Research (NIPER), Hajipur
Vaishali
BIHAR
844101
India |
| Phone |
8447331409 |
| Fax |
|
| Email |
bhatnagarsurabhi44@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Post Graduate Thesis] |
|
|
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 |
| DrYP Singh |
Max Super Speciality Hospital |
Max Super Speciality Hospital
(A Unit of Balaji Medical and Diagnostic Research Centre)
108A, Indraprastha Extension, Patparganj, Delhi- 110092
New Delhi
DELHI |
08800531155
yogendra.singh2@maxhealthcare.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 |
Severe Sepsis/ Septic Shock, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Patients with severe sepsis/septic shock admitted to the medical intensive care unit.
•Patients aged above 18 years and below 65 years
•Patients who are receiving antimicrobial agents.
|
|
| ExclusionCriteria |
| Details |
•Patients with less than 8 hours of length of stay in the ICU. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the major antibiotic prescribed in Gram- negative severe sepsis/ septic shock patients admitted in MICU.
2. To determine the Gram- negative micro-organism isolated in the positive culture and their sensitivity against the antimicrobial agents.
|
After recruitment we analyze our outcome. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
11/12/2013 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Publication of the result will be on the discernment of the Chief guide. Subject identity will not be revealed and confidentiality will be maintained.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
|
Protocol Title
|
A
prospective observational study to evaluate the prescribing pattern and
microbial sensitivity of antimicrobial agents in Gram-negative severe
sepsis/septic shock patients in medical intensive care unit at tertiary care
hospital.
|
|
Protocol No:
|
PPMS-01
|
|
Version number
|
1.0, Dated-5/09/13
|
|
Primary objective
Secondary objective
|
To evaluate the prescribing pattern and microbial
sensitivity of antimicrobial agents in Gram- negative severe sepsis/ septic
shock patients in MICU at tertiary care hospital.
1. To
determine the epidemiology of Gram- negative severe sepsis/septic shock in
MICU at tertiary care hospital.
2. To
determine the clinical outcomes of Gram- negative severe sepsis/septic shock
patients admitted in the MICU.
|
|
Study design
|
Prospective Observational study
|
|
Study Duration
|
6 months
|
|
Methodology
|
In this study, data of the
patients, who suffered from Gram-negative severe sepsis/septic shock, will be
collected prospectively, from MICU, Max Super Specialty Hospital, Patpargunj,
New Delhi, and the prescribing pattern and microbial sensitivity will be
studied and evaluated
|
|
Study Population
|
Both males and females
|
|
Data Collection
|
All
the variables will be noted in the data collection sheet.
|
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Ethics and Responsibility
|
The protocol will be submitted to IEC of Max Super
Specialty Hospital.
|
|