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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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