Genotyping of carbapenemase enzymes produced by CRE and Aztreonam Ceftazidime Avibactam synergy testing for MBL producers

Not yet recruiting

Conditions: Escherichia coli [E. coli ] as thecause of diseases classified elsewhere,

Registration Number: CTRI/2025/04/085861

Lead Sponsor: NA

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 170

Inclusion Criteria

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.

Exclusion Criteria

Carbapenem resistant Gram-negative bacteria other than Enterobacterales are excluded.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the prevalence of carbapenemase production among the Enterobacterale	18 Months
isolates from clinical specimens received for routine culture and sensitivity in Dept. of	18 Months
Microbiology	18 Months

Secondary Outcome Measures

Name	Time	Method
2. To detect different genes responsible for carbapenemase production among	Enterobacterales

Trial Locations

Locations (1): Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Dr Himabindu Vennelaganti
Principal investigator
9618938168
himabindu.v2@gmail.com