| CTRI Number |
CTRI/2024/05/068161 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the association of antibiotic resistance, genes responsible, biofilm production in Acinetobacter baumanii isolates |
|
Scientific Title of Study
|
Association of multidrug resistance, virulence genes and biofilm production among clinical isolates of Acinetobacter baumanii |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jagriti |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9301649483 |
| Fax |
|
| Email |
jagriti.vaidya.31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Saxena |
| Designation |
Head of department and Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no 19, Department of Microbiology, Pathology block, Ground floor, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9811349053 |
| Fax |
|
| Email |
sonalsaxena3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Saxena |
| Designation |
Head of department and Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no 19, Department of Microbiology, Pathology block, Ground floor, Maulana Azad Medical College, New Delhi
DELHI
110002
India |
| Phone |
9811349053 |
| Fax |
|
| Email |
sonalsaxena3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi,India,110002 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Jagriti |
Maulana Azad Medical College, New Delhi |
Department of Microbiology,
Pathology block, room no 19, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI |
9301649483
jagriti.vaidya.31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All isolates of Acinetobacter baumanii isolated from clinical specimens of pus, blood, body fluids suspected to be a pathogen |
|
| ExclusionCriteria |
| Details |
Repeat sample from same patient with isolation of Acinetobacter baumanii |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Association between biofilm formation and multidrug resistance
2. Correlation between MIC and biofilm formation. |
1 YEAR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of isolates which are multidrug resistant, biofilm producer
2. Mechanism of carbapenem resistance observed in Acinetobacter baumanii
3. Genes responsible for biofilm production in Acinetobacter baumanii |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
16/06/2024 |
| 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 Applicable |
| 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
|
Acinetobacter baumanii is a gram negative coccobacillus and a critical priority pathogen usually found in patients of Intensive Care Unit. This thesis aims at determining the association between multidrug resistance, virulence genes and biofilm formation in Acinetobacter baumanii. The primary objectives are to study antimicrobial resistance pattern of Acinetobacter baumanii obtained from clinical specimens and to determine biofilm production in Acinetobacter baumanii. The secondary objectives are to characterize the mechanisms of carbapenem resistance in Acinetobacter baumanii and determine the genes responsible for biofilm production in Acinetobacter baumanii. The study will be conducted in bacteriology laboratory of Maulana Azad Medical College, New Delhi. |