| CTRI Number |
CTRI/2023/04/051953 [Registered on: 25/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study conducted in a tertiary care hospital for a period of one year, aims to observe the number of new cases and better understand the treatment of infections caused by bacteria belonging to Enterobacteriaceae species that are resistant to an antibiotic class called Carbapenems. |
|
Scientific Title of Study
|
Management of Carbapenem Resistant Enterobacteriaceae infection - a cross sectional study in a 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 |
Gaurav Girish |
| Designation |
PharmD student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
6362262070 |
| Fax |
|
| Email |
gaurav.girish1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Kumar Shetty |
| Designation |
Assistant Professor - Senior scale |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
07019950009 |
| Fax |
|
| Email |
prasanna.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Girish |
| Designation |
PharmD student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
6362262070 |
| Fax |
|
| Email |
gaurav.girish1@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college and Hospital |
| Self |
|
|
Primary Sponsor
|
| Name |
Gaurav Girish |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka.576104 |
| 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 |
| Gaurav Girish |
KASTURBA HOSPITAL |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka.576104
Udupi
KARNATAKA |
06362262070
gaurav.girish1@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J150||Pneumonia due to Klebsiella pneumoniae, (2) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (3) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ADULT PATIENT WITH CRE INFECTION CAUSED BY E.COLI OR K.PNEUMONIAE |
|
| ExclusionCriteria |
| Details |
PATIENTS WHO DO NOT PROVIDE CONSENT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INCIDENCE OF CRE INFECTIONS and COMPARISION OF MANAGEMENT GUIDELINES FOLLOWED IN TERTIARY CARE HOSPITAL WITH ICMR GUIDELINES |
April 2023 to March 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPARISION OF MANAGEMENT WITH ICMR GUIDELINES |
MAY 2023 TO MAY 2024 |
|
|
Target Sample Size
|
Total Sample Size="139"
Sample Size from India="139"
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)
|
01/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE MAIN OBJECTIVE IS TO DETERMINE CRE INCIDENCE IN A SOUTH INDIAN TERTIARY CARE HOSPITAL THE SECONDARY OBJECTIVE IS TO COMPARE THE MANAGEMENT OF CURRENT TREATMENT VS ICMR GUIDELINES |