| CTRI Number |
CTRI/2024/02/062637 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of organisms causing respiratory tract infections in ICU patients focusing on Acinetobacter baumannii
|
|
Scientific Title of Study
|
Prevalence of pathogens in respiratory tract infections in ICU patients with the detection of Colistin susceptibility in Acinetobacter baumannii |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEDHA |
| Designation |
Post graduate Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867512856 |
| Fax |
|
| Email |
medharbhat9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical Collge |
| Address |
Department of Microbiology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
MEDHA |
| Designation |
Post graduate Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867512856 |
| Fax |
|
| Email |
medharbhat9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post – Graduate Student Research Grant Kasturba Medical College |
|
|
Primary Sponsor
|
| Name |
Medha |
| Address |
Department of Microbiology
Kasturba Medical College
Manipal |
| 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 |
| Dr Chiranjay Mukhopadhyay |
Kasturba Medical College, Manipal |
2nd floor, Basic Sciences building,
Department of Microbiology,
Manipal.
Udupi
KARNATAKA |
9845513057
chiranjay.m@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: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above 18 years of age whose respiratory samples will be culture positive for
Acinetobacter baumannii.
2.The respiratory samples from the Intensive Care Unit of the hospital. |
|
| ExclusionCriteria |
| Details |
1.Patients less than 18 years of age.
2. Pregnant women
3. The samples other than respiratory samples. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detection of colistin susceptibility by BMD method. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimation of prevalence of the organisms isolated from the respiratory tract infection in ICU patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "313"
Final Enrollment numbers achieved (India)="313" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2024 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="16" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acinetobacter baumannii is a nosocomial pathogen that causes a wide variety of diseases including respiratory tract, bloodstream, urinary tract, surgical site, and wound infections. Over the decades, there has been an increased resistance pattern observed in A.baumannii which has lead to few effective treatment options. Colistin is a one of the last resort antibiotics used to treat infections caused by Multidrug resistant A.baumannii.. Therefore, it is essential to comprehend A. baumannii colistin susceptibility patterns in order to control infections brought on by this pathogen effectively. The main aim of the study is to evaluate the resistance profile of Acinetobacter baumannii isolated from respiratory samples through automated system and broth microdilution method for colistin. The study also focuses on determining the prevalence of the clinically significant etiological agents isolated from respiratory samples in Intensive Care Unit. The susceptibility of colistin will be performed by the Broth Microdilution method (BMD) and automated Vitek2.The outcome of this study will be determining the prevalence rates of clinically significant etiological agents from respiratory samples in Intensive Care unit (ICU).This study compares the efficacy of colistin with other antibiotics that has activity against A. baumannii. |