| CTRI Number |
CTRI/2025/04/085861 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Genotyping of carbapenemase enzymes produced by CRE and Aztreonam Ceftazidime Avibactam synergy testing for MBL producers |
|
Scientific Title of Study
|
Genotyping of Carbapenem resistant
Enterobacterales and Aztreonam and ceftazidime/ avibactam synergy testing against MBL
producing Enterobacterales in a Tertiary Cancer Care Centre, Visakhapatnam. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himabindu Vennelaganti |
| Designation |
Clinical Microbiologist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Department of Microbiology, 1st floor, Main building, Plot 212, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi (V), Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
9618938168 |
| Fax |
|
| Email |
himabindu.v2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himabindu Vennelaganti |
| Designation |
Clinical Microbiologist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Department of Microbiology, 1st floor, Main building, Plot 212, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi (V), Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
9618938168 |
| Fax |
|
| Email |
himabindu.v2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himabindu Vennelaganti |
| Designation |
Clinical Microbiologist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Department of Microbiology, 1st floor, Main building, Plot 212, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi (V), Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
9618938168 |
| Fax |
|
| Email |
himabindu.v2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Himabindu Vennelaganti |
Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam |
1st floor, Main building, Department of Microbiology
Visakhapatnam
ANDHRA PRADESH |
9618938168
himabindu.v2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBCH RC Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Carbapenem-resistant Enterobacterale isolates from clinical specimens, including pus, urine, body fluids, sputum, and blood samples, received in the microbiology laboratory for culture and sensitivity testing |
|
| ExclusionCriteria |
| Details |
Carbapenem resistant Gram-negative bacteria other than Enterobacterales are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the prevalence of carbapenemase production among the Enterobacterale
isolates from clinical specimens received for routine culture and sensitivity in Dept. of
Microbiology |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. To detect different genes responsible for carbapenemase production among
Enterobacterales
3. To evaluate the synergy of ceftazidime/ avibactam - aztreonam combination on the
confirmed MBL producing Enterobacterales in vitro |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
10/06/2025 |
| 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
|
Study title Genotyping of Carbapenem resistant Enterobacterales and Aztreonam and ceftazidime/ avibactam synergy testing against MBL producing Enterobacterales in a Tertiary Cancer Care Centre Visakhapatnam This study focuses on addressing a critical public health issue the increasing resistance of certain bacteria to antibiotics which makes infections harder to treat Specifically we are examining bacteria from the Enterobacterales family which have developed resistance to a group of antibiotics called carbapenems These antibiotics are usually reserved for severe infections that do not respond to other treatments Unfortunately some bacteria have developed the ability to resist even these powerful antibiotics leading to significant concerns in the medical community. Our study aims to understand how common this resistance is among bacteria found in patients at a cancer care center We are particularly interested in a type of resistance caused by enzymes called Metallo-beta-lactamases which break down carbapenem antibiotics making them ineffective These enzymes are produced due to certain genes within the bacteria We will also test whether a combination of two drugs Aztreonam and CeftazidimeAvibactam can effectively work together to fight these resistant bacteria If successful this combination could provide a new option for treating infections that are difficult to manage with existing antibiotics Objectives 1 To find out how many Enterobacteriaceae bacteria from clinical samples can produce carbapenemase 2 To identify the specific genes that cause these bacteria to produce carbapenemase 3 To test if the combination of CeftazidimeAvibactam and Aztreonam works well against these bacteria in the lab This is an observational study where we will analyse samples from patients who are being treated at the cancer care center For this study we will use samples already collected from patients for routine testing We will then conduct additional tests to identify any resistance genes and evaluate how well the drug combination works against these resistant bacteria. The study will take place over 12 months Expected Outcomes We hope to provide valuable information that can help doctors choose the most effective treatment options for patients who are infected with these resistant bacteria By understanding how these bacteria resist treatment and exploring new ways to combat them we can improve patient care and contribute to the global fight against antibiotic resistance |