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CTRI Number  CTRI/2024/03/063923 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 09/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   study of how antibiotics opposing to action on different bacterial diseases. 
Scientific Title of Study   Bacteriological profile and antibiotic resistance pattern of isolates among intensive care unit in a tertiary care teaching hospital: A prospective cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karedla Srinivasu 
Designation  Assistant Professor 
Affiliation  mahavir institute of medical sciences 
Address  Sf-6 Mahavir institute of medical sciences Department of Pharmacology Vikarabad Telangana

Mahbubnagar
TELANGANA
501101
India 
Phone  9177582808  
Fax    
Email  karedlasrinivasu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Karedla Srinivasu 
Designation  Assistant Professor 
Affiliation  mahavir institute of medical sciences 
Address  Department of pharmacology SF-6 STEACHING STAFF QUARTERS MAHAVIR INSTITUTE OF MEDICAL SCIENCES vikarabad Telangana


TELANGANA
501101
India 
Phone  9177582808  
Fax    
Email  karedlasrinivasu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karedla Srinivasu 
Designation  Assistant Professor 
Affiliation  mahavir institute of medical sciences 
Address  Department of Pharmacology Sf-6 Teaching staff quarters Mahavir institute of medical sciences vikarabad Telangana

Mahbubnagar
TELANGANA
501101
India 
Phone  9177582808  
Fax    
Email  karedlasrinivasu@gmail.com  
 
Source of Monetary or Material Support  
Mahavir institute of medical sciences. Sivareddypet Vikarabad-501101 Telangana India 
 
Primary Sponsor  
Name  Mahavir institute of medical sciences 
Address  MIMS Vikarabad  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 K Srinivasu  Mahavir institute of medical sciences  Central Laboratory Room No:2
Mahbubnagar
TELANGANA 		 9248413447

karedlasrinivasu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Mahavir institute of medical sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A499||Bacterial infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  all the persons, who are admitted in intensive care units 
 
ExclusionCriteria 
Details  Those who are already on antibiotic treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Present study will be forms a useful reference for clinical microbiologists, physicians
and others attempting to monitor the prevalence of septicemia and for the treatment of
patients with such infection. Utilizing various methods for reduction of development of
antibiotic resistance is utmost requirement which can be established by adopting specific
antibiotic utilization strategies e.i., reducing antibiotic usage, developing combination
therapy, using antibiotic only after standard antimicrobial susceptibility testing and recycling
of antibiotic. Use methods for proper infection control and proper channelization of antibiotic
programs are most important and are of prime requirement.
This study will be indicating need for periodic surveillance detection of causative
agents of blood stream infections and their antibiogram in the hospital which can guide for
selection of appropriate choice of empiric therapy. 		 one year 
 
Secondary Outcome  
Outcome  TimePoints 
This study will be indicating need for periodic surveillance detection of causative
agents of blood stream infections and their antibiogram in the hospital which can guide for
selection of appropriate choice of empiric therapy. 		 one year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   19/03/2024 
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="0"
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  
Resistance to anti microbial agents is a major factor associated with bad outcome of sepsis, that is a crucial medical emergency. one of the main concerns in blood infection is Multi drug resistance (MDR). The infection caused by MDR organism is more likely to prolong the hospital stay, increase the risk of death and require the treatment with more expensive antibiotics. Thus we aim the present study is to assess the bacteriological profile in positive isolates among ICU patients and also evaluate the pattern of antibiotic resistance.
Present study will be forms a useful reference for clinical microbiologists,physicians and others attempting to monitor the prevalence of septicemia and for the treatment of patients with such infection.
This study will be indicating need for periodic surveillance detection of causative agents of blood stream infections and their antibiogram in the hospital which can guide the selection of appropriate choice of empiric therapy. 
 
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