| CTRI Number |
CTRI/2025/07/091845 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of incidence, resistance patterns, efficacy of ceftazidime-avibactam and aztreonam in critically ill patients with carbapenem resistant enterobacterales (CRE) infection in a tertiary care setup- A prospective observational study |
|
Scientific Title of Study
|
Study of incidence, resistance patterns, efficacy of ceftazidime-avibactam and aztreonam in critically ill patients with carbapenem resistant enterobacterales (CRE) infection in a tertiary care setup- A prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
priyanka sagar |
| Designation |
DrNB critical care medicine resident |
| Affiliation |
BLK MAX SUPERSPECIALITY HOSPITAL |
| Address |
B-6/83,84 sector-8 rohini delhi-85
Central
DELHI
110085
India |
| Phone |
9971498506 |
| Fax |
|
| Email |
96priyankasagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
priyanka sagar |
| Designation |
DrNB critical care medicine resident |
| Affiliation |
BLK MAX SUPERSPECIALITY HOSPITAL |
| Address |
B-6/83,84 sector-8 rohini delhi-85
Central
DELHI
110085
India |
| Phone |
9971498506 |
| Fax |
|
| Email |
96priyankasagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
priyanka sagar |
| Designation |
DrNB critical care medicine resident |
| Affiliation |
BLK MAX SUPERSPECIALITY HOSPITAL |
| Address |
B-6/83,84 sector-8 rohini delhi-85
Central
DELHI
110085
India |
| Phone |
9971498506 |
| Fax |
|
| Email |
96priyankasagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLK MAX SUPERSPECIALITY HOSPITAL |
|
|
Primary Sponsor
|
| Name |
BLK MAX SUPERSPECIALITY OSPITAL |
| Address |
PUSA ROAD, NEW DELHI-110005 |
| 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 |
| PRIYANKA SAGAR |
BLK MAX SUPERSPECIALITY HOSPITAL |
PUSA ROAD, NEW DELHI-110005
Central
DELHI |
9971498506
96priyankasagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLK MAX SUPERSPECIALITY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B961||Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
?18 years |
|
| ExclusionCriteria |
| Details |
PREGNANT PATIENTS
PATIENT UNLIKELY TO SURVIVE BEYOND 48 HOUR
CANCER DIAGNOSIS
IMMUNOSUPPRESSIVE/ANTI CANCER THERAPY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO FIND THE INCIDENCE OF CRE INFECTION AND 28 DAY MORTALITY IN ADULT PATIENTS ADMITTED IN MICU |
TO FIND THE INCIDENCE OF CRE INFECTION AND 28 DAY MORTALITY IN ADULT PATIENTS ADMITTED IN MICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE TIME TO MICROBIOLOGICAL AND CLINICAL CURE IN ADULT PATIENTS WITH CRE IN ICU |
|
| TO STUDY THE RISK FACTORS, ANTIBIOTIC SUSCEPTIBILITY AND RESISTANCE PATTERN (MIC VALUE AND BREAK POINTS) IN ADULT PATIENTS WITH CRE IN ICU |
|
TO STUDY THE FOLLOWING
synergy between CAZ-AVI+ATM
number of ventilator days
days on renal replacement therapy
ICU length of stays |
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
08/08/2025 |
| 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)
|
Open to Recruitment |
| 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 of incidence, resistance patters, efficacy of ceftazidime-avibactam and aztreonam in critically ill patients with carbap[enem resistant enterobacterales infection in tertiary care setup-a prospective observational study |