| CTRI Number |
CTRI/2024/06/069235 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Detection of Antibiotic Sensitivity and Resistance Pattern of Klebsiella Pneumoniae Bacteria in the Samples Received from Patients of Hospital |
|
Scientific Title of Study
|
Identification and Antibiogram Profile of Klebsiella pneumoniae in Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Shriram Ghule |
| Designation |
Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology,
2nd floor, Jawaharlal Nehru Medical College (DMIHER) Sawangi Meghe Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9405074052 |
| Fax |
|
| Email |
vishalghule5701@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dhruba Hari Chandi |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology,
2nd floor, Jawaharlal Nehru Medical College (DMIHER) Sawangi Meghe Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9584543658 |
| Fax |
|
| Email |
dhrubachandi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dhruba Hari Chandi |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology,
2nd floor, Jawaharlal Nehru Medical College (DMIHER) Sawangi Meghe Wardha
MAHARASHTRA 442001 India |
| Phone |
9584543658 |
| Fax |
|
| Email |
dhrubachandi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Vishal Shriram Ghule |
Acharya Vinoba Bhave Rural Hospital |
Department of Microbiology, 2nd floor, Jawaharlal Nehru Medical College (DMIHER), Sawangi Meghe, Wardha Wardha MAHARASHTRA |
9405074052
vishalghule5701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All isolates that form pink, lactose fermenting, mucoid colonies on MacConkey agar and large dome shaped colonies on blood agar and further confirmed Klebsiella pneumoniae by biochemical tests will be included |
|
| ExclusionCriteria |
| Details |
All isolates other than Klebsiella pneumoniae will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The data obtained from the present study can be used to determine trends in antimicrobial resistance of Klebsiella pneumoniae to formulate local antibiotic policy |
1 year, 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/08/2024 |
| 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="1" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Klebsiella pneumoniae is a gram-negative, capsulated, non-motile, lactose fermenting, facultative anaerobic bacilli, belonging to family Entero-bacteriaceae. It is one of the most common agents responsible for causing hospital and community acquired infections, and it is resistant to a wide range of antibiotics. It is intrinsically resistant to ampicillin. It is one of the most common opportunistic and nosocomial pathogen causing pneumonia, pyogenic infections, meningitis, urinary tract infections (UTI) and rarely diarrhea and it mostly targets immunocompromised, hospitalized individuals associated with diabetes mellitus, chronic pulmonary, cardiac, renal and neoplastic diseases. They are widely distributed in nature and can be found in the gastrointestinal tract of humans and animals. For the present study, we will monitor all samples that we receive in microbiology lab. These samples will be processed as per standard bacteriological techniques for aerobic cultures. They will be inoculated on the Blood, Nutrient and MacConkey agar plates and incubated at 37°C for 24-48 hours. For further confirmation biochemical test will be performed with these isolates. These isolates of Klebsiella pneumoniae now will be separated for study on their drug resistance pattern. The data obtained from the present study can be used to determine trends in antimicrobial resistance of Klebsiella pneumoniae to formulate local antibiotic policy. It will help in regular monitoring of the antimicrobial susceptibility profile of drugs.This will aid medical professionals in choosing the best chemotherapy, which will improve infection control and patient care. |