An observational study to estimate the antibiotics resistance in critically ill patients and to compare risk factors for resistance to antibiotics .

Not yet recruiting

• Conditions: Bacterial infection, unspecified,

• Registration Number: CTRI/2022/03/041515
• Lead Sponsor: EHCC hospitaljaipur

Brief Summary

Antibiotics resistance has been emerging as a con in medical practice, specially in critically ill patients.

It is important to know factors responsible for development of resistance to antibiotics.

In last few years, resistance to broad spectrum antibiotics including carbapenems has emerged as a more serious concern.

In this study, we want to know whether factors responsible for development of resistance to  carbapenem antibiotics  are different from factors for resistance to other antibiotics.

Primary objective of this  prospective observational comparative study is to compare risk factors for carbapenem resistance and non carbapenem resistance in critically ill patients.

Secondary objectives are to know prevalence of carbapenem resistant bacteria and distribution of different genetic pattern of carbapenem resistance.

Study will involve ICU patients having growth of  resistant gram negative bacilli, for a period of one year .

Patients will be divided into two groups -A. carbapenem resistant  B. non carbapenem resistant ,but resistant to at least one other antibiotic.

Different risk factors would be noted (as per study proforma )from detailed patient history,examination,investigations,treatment & outcome of patient in both groups.

PCR based ,FDA approved test would be done to know genetic pattern of carbapenem resistance on some patients (as per clinician decision).

Study will not interfere in sending any investigation or in management of patient,(Management & tests would be done only as per treating physician).

All important risk factors would be compared between above mentioned groups A & B like previous exposure to antibiotics, comorbidites, presence of indwelling devices,severity of illness etc

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-30
• Study Start: 2022-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients admitted in medical ICU at eternal hospital during study period,patients showing growth of gram negative bacilli in any culture.

Exclusion Criteria

• 1.Organisms grown in culture ,but in insignificant colony count.
• Gram negative bacilli sensitive to all antibiotics.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of risk factors (Admission source, Comorbidities, previous exposure to antibiotics, indwelling catheters, mechanical ventilation, severity of illness) for carbapenem resistance and noncarbapenem resistant gram negative bacilli.	baseline

Secondary Outcome Measures

Name	Time	Method
To know the prevalence of carbapenem resistance in gram negative bacilli.
To compare 30 day mortality between the two groups	30 day
To know the distribution of different genetic pattern of carbapenem resistance in gram negative bacilli.	baseline

Trial Locations

Locations (1)

Eternal Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Eternal Hospital

🇮🇳Jaipur, RAJASTHAN, India

Yatendra kumar gupta

Principal investigator

8826073126

dryatendragupta@gmail.com