| CTRI Number |
CTRI/2022/03/041515 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
30/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to estimate the antibiotics resistance in critically ill patients and to compare risk factors for resistance to antibiotics . |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL COMPARATIVE STUDY OF PREVALENCE AND RISK FACTORS FOR CARBAPENEM RESISTANCE AND NON CARBAPENEM RESISTANCE IN GRAM NEGATIVE BACILLI IN CRITICALLY ILL PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatendra kumar gupta |
| Designation |
Consultant |
| Affiliation |
Eternal Heart Care Hospital ,jaipur |
| Address |
Department of Critical care medicine, 1st floor, Medical ICU, 3A, Jagatpura road,near jawahar circle, Jaipur, 302017
41,SHIV COLONY,BEHIND ARCHNA HOSPITAL,NEAR SANGANER THANA,JAIPUR,RAJASTHAN 302029
Jaipur
RAJASTHAN
302017
India |
| Phone |
8826073126 |
| Fax |
|
| Email |
dryatendragupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kishore mangal |
| Designation |
senior consultant |
| Affiliation |
Eternal heart care hospital ,jaipur |
| Address |
Department of Critical care medicine, 1st floor, Medical ICU, 3A, Jagatpura road,near jawahar circle, Jaipur, 302017
Jaipur
RAJASTHAN
302017
India |
| Phone |
9982212486 |
| Fax |
|
| Email |
drkishoremangal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore Mangal |
| Designation |
Senior Consultant |
| Affiliation |
Eternal heart care hospital ,jaipur |
| Address |
Department of Critical care medicine, 1st floor, Medical ICU, 3A, Jagatpura road,near jawahar circle, Jaipur, 302017
Jaipur
RAJASTHAN
302017
India |
| Phone |
9982212486 |
| Fax |
|
| Email |
drkishoremangal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical care medicine, 1st floor, Eternal Hospital, 3A, Jagatpura Rd, near Jawahar Circle, Chainpura, Malviya Nagar, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
EHCC hospitaljaipur |
| Address |
3A,jagatpura road,near jawahar circle,jaipur,302017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Yatendra kumar gupta |
Eternal Hospital |
Department of Critical care medicine, 1st floor, Medical ICU, 3A, Jagatpura road,near jawahar circle, Jaipur, 302017
Jaipur
RAJASTHAN |
8826073126
dryatendragupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Eternal heart care centre and research institute institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in medical ICU at eternal hospital during study period,patients showing growth of gram negative bacilli in any culture |
|
| ExclusionCriteria |
| Details |
1.Organisms grown in culture ,but in insignificant colony count.
2. Gram negative bacilli sensitive to all antibiotics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
To know the prevalence of carbapenem resistance in gram negative bacilli.
|
baseline |
| To know the distribution of different genetic pattern of carbapenem resistance in gram negative bacilli. |
baseline |
| To compare 30 day mortality between the two groups |
30 day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/04/2022 |
| 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
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
|