| CTRI Number |
CTRI/2024/06/069303 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Antimicrobial Utilization In Hospital |
|
Scientific Title of Study
|
Antimicrobial Utilization In A Intensive Care Unit Of A Tertiary Care Hospital-PG Dissertation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnan prem |
| Designation |
Post Graduate |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department Of Pharmacology,
Sri Devaraj Urs Medical College,
Tamaka, Kolar
Kolar KARNATAKA 563101 India |
| Phone |
9447790835 |
| Fax |
|
| Email |
krishnansuryaster@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sarala N |
| Designation |
Professor and Head |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department Of Pharmacology,
Sri Devaraj Urs Medical College,
Tamaka,Kolar
Kolar KARNATAKA 563101 India |
| Phone |
9845750165 |
| Fax |
|
| Email |
saralan@sduaher.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sarala N |
| Designation |
Professor and Head |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar KARNATAKA 563101 India |
| Phone |
9845750165 |
| Fax |
|
| Email |
saralan@sduaher.ac.in |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College,Tamaka,Kolar,Karnataka,India,Pin 563101 |
|
|
Primary Sponsor
|
| Name |
krishnan Prem |
| Address |
Post Graduate,Department Of Pharmacology,Sri Devaraj Urs Medical College, Tamaka, Kolar,Karnataka,Pin 563101 |
| 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 |
| DrKrishnan Prem |
R L Jalappa Hospital and Research Centre, Sri Devaraj Urs Medical College |
Intensive Care Unit, Ground Floor,Department Of Anaethesia,Sri Devaraj Urs Medical College,Tamaka,Kolar India
Pin: 563101
Kolar KARNATAKA |
9447790835
krishnansuryaster@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central ethics committee,Sri Devaraj Urs Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (3) ICD-10 Condition: G01||Meningitis in bacterial diseases classified elsewhere, (4) ICD-10 Condition: T07||Unspecified multiple injuries, (5) ICD-10 Condition: T36-T50||Poisoning by, adverse effect of and underdosing of drugs, medicaments and biological substances, (6) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, (7) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of either gender
2)Patients aged between 18-80 years admitted to ICU receiving antimicrobial agents and/or drugs for peptic ulcer
3)Patient who are in ICU for 1-5 days
|
|
| ExclusionCriteria |
| Details |
1)Patients on dialysis
2)Patients on ventilator
3)Patients who stayed less than 24 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will show the utilization pattern of antimicrobials in intensive care unit and shows the relationship between Prescribed Daily Dose and WHO defined Daily Dose. |
6 months,9 months,12 months,
15 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It wil show the drugs used in peptic ulcer & will reveal the cost of antimicrobial therapy in intensive care unit |
6 months,9 months,12 months,
15 months. |
|
|
Target Sample Size
|
Total Sample Size="634" Sample Size from India="634"
Final Enrollment numbers achieved (Total)= "650"
Final Enrollment numbers achieved (India)="650" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/07/2024 |
| Date of Study Completion (India) |
30/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Globally there is inappropriate use of antimicrobial agents (AMA) resulting in rise of antimicrobials resistance and this has become an important issue particularly in patients in intensive care units (ICUs). A study has shown that physicians commonly prescribe antimicrobials for longer durations than indicated by guidelines. In this they identified many factors that influence prescribing patterns like severity of the illness, the patient’s comorbidities, and the physician’s level of experience. Rapid and correct diagnosis will minimize the use of empiric broad-spectrum antimicrobials there by providing focused antimicrobial therapy. Over time, the necessity of newer antimicrobials has been increasing , more so in the ICU because of the clinical condition the patients present to the physician. Our study will determine the utilization pattern of antimicrobials based on WHO prescribing indicators in Intensive care unit, also the relationship between Prescribed Daily Dose and WHO Defined Daily Dose and we will also assess the drugs used in peptic ulcers because most of the patients in Intensive care unit will be receiving them. It will also assess the cost of antimicrobial therapy in Intensive care unit.
|