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CTRI Number  CTRI/2021/07/035228 [Registered on: 28/07/2021] Trial Registered Prospectively
Last Modified On: 22/07/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Disease causing ability, and medical effects of bacterial infections in ICU to understand challenges and opportunities for prevention. 
Scientific Title of Study   Pathogenicity,resistance attributes and clinical impact of Acinetobacter baumannii complex infections in ICU settings to understand challenges and opportunities for prevention. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasa C Tantry  
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, Basic Science Building, 2nd floor Kasturba Medical College Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8884940232  
Fax    
Email  manasactantry@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana K E 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology Basic Science Building, 2nd floor Kasturba Medical College Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902206009  
Fax    
Email  vandanake@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manasa C Tantry  
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology Basic Science Building, 2nd floor Kasturba Medical College Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8884940232  
Fax    
Email  manasactantry@gmail.com  
 
Source of Monetary or Material Support  
Manipal academy of Higher Education, Madhavnagar, Manipal, Udupi, Karnataka 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education Manipal 
Address  Kasturba Medical College Manipal Academy of Higher Education Madhavnagar Manipal Udupi -576104 
Type of Sponsor  Research institution and hospital 
 
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 
Manasa C Tantry  Kasturba Medical College and Hospital, Manipal  Department of Microbiology, Basic Sciences Building, KMC Madhavnagar, Manipal -576104
Udupi
KARNATAKA 
8884940232

manasactantry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult inpatients with blood culture positive for Acinetobacter baumannii complex admitted in Kasturba Hospital.
 
 
ExclusionCriteria 
Details  Patients known to have confirmed A. baumannii complex bacteremia, prior admission to the hospital. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical and epidemiological features associated with the A. baumannii bacteremia and the incidence will be known.   3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Molecular basis of drug resistance and the pathogenicity will be learnt
 
1 year 
 
Target Sample Size   Total Sample Size="163"
Sample Size from India="163" 
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)   02/08/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Acinetobacter baumannii complex is the common cause of nosocomial Bloodstream infections (BSI) in the ICUs with the crude mortality rates ranging from 20-60% . Multidrug resistant Acinetobacter baumannii (MDRAb) has been regarded as a serious threat as it accounted for an estimated annual death of 500 and an estimated number of 7300 cases annually in the US. The World Health Organization has regarded Carbapenem resistant Acinetobacter baumannii (CRAB) as critical and has been given number 1 priority in the pathogen list for Research and development of new antibiotics in 2017.

Method: Patients with A. baumannii bacteremia will be followed prospectively through hospital discharge or death. Patients’ demographic, clinical, and laboratory data will be collected. This would provide the epidemiological and antimicrobial susceptibility data for Acinetobacter bacteremia over a period of 3 years. Clinical manifestations, Risk factors for Acinetobacter bacteremia will also be assessed.  Molecular Characterization of Resistance determinants and Detection of Virulence factors will be done on the clinical isolates of Acinetobacter baumannii complex collected and this would demonstatre the resistance pattern and the most prevalent drug resistant Acinetobacter in our setting.

Relevance of the study: A baumannii complex is emerging as a predominant  cause of nosocomial bloodstream infections. Throughout the globe, they are being held responsible to be the most common adverse effect jeopardizing the patients’ welbeing. Since A. baumannii complex has the propensity to colonize and infect debilitated patients, it is imperative to understand the burden and clinical impact on the patient outcome. Novel data on the virulence attributes and the resistance determinants could further pave way in the development of potential targets for antimicrobial agents. 


 
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