| 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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
|
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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. |
|
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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
|
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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. |