| CTRI Number |
CTRI/2026/02/103259 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Combination of Ceftazidime-avibactam and Aztreonam for treatment of bloodstream infections caused by Metallo-B-lactamase producing enterobacteriaceae- a prospective observational study |
|
Scientific Title of Study
|
Combination of Ceftazidime-avibactam and Aztreonam for treatment of bloodstream infections caused by Metallo-B-lactamase producing enterobacteriaceae- 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 |
Dr Aditi Kaushal |
| Designation |
DrNB student |
| Affiliation |
Sir gangaram hospital, new delhi |
| Address |
Department of Critical Care Medicine,
Sir Ganga Ram Hospital,
Old Rajinder Nagar, New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9619182536 |
| Fax |
|
| Email |
draditikaushal294@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Kaushal |
| Designation |
DrNB student |
| Affiliation |
Sir gangaram hospital, new delhi |
| Address |
Department of Critical Care Medicine,
Sir Ganga Ram Hospital,
Old Rajinder Nagar, New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9619182536 |
| Fax |
|
| Email |
draditikaushal294@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Kaushal |
| Designation |
DrNB student |
| Affiliation |
Sir gangaram hospital, new delhi |
| Address |
Department of Critical Care Medicine,
Sir Ganga Ram Hospital,
Old Rajinder Nagar, New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9619182536 |
| Fax |
|
| Email |
draditikaushal294@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital- Infrastructure Support |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prakash Shastri |
Sir Ganga Ram Hospital |
Department of Critical Care Medicine,
Sir Ganga Ram Hospital,
Old Rajinder Nagar, New Delhi
New Delhi
DELHI |
9810937295
prakashshastri@live.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z163||Resistance to other antimicrobialdrugs, (2) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ceftazidime-avibactam + Aztreonam |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Other Active Agents (Colistin, Tigecycline, Fosfomycin, Amikacin, Meropenem) |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients must be more than or equal to 18 years of age, both males and females.
Patients have a confirmed diagnosis (blood culture positive) of bloodstream infection (BSI) requiring administration of intravenous (IV) antibacterial therapy.
Patients must have an MBL-positive Enterobacterales (for which the imipenem or meropenem minimum inhibitory concentrations is reported as more than or equal to 4 mg/L) isolated from blood within 48 hours prior to enrolment.
Patient admitted in ICU.
In the case of mixed infection, the patient was allowed to participate in the study if the species were deemed susceptible to Ceftazidime-avibactam + Aztreonam combination (CAZ-AVI + ATM) or the investigator considered that the additional species were colonizers which did not warrant specific treatment.
Patients with BSI, with signs and symptoms of systemic infection characterized by at least one of the following:
Chills, rigors or fever (temperature of more than or equal to 38.0°C or more than or equal to 100.4°F).
Elevated WBC count (more than or equal to 10 000/mm3) or left shift ( more than or equal to 15% immature polymorphonuclear leukocytes).
|
|
| ExclusionCriteria |
| Details |
Patients with positive culture for any infection prior to ICU admission
Pregnant and nursing mothers
Patient readmitted to the ICU
Patient admitted with burns
Patient with known HIV seropositivity
Patient had a history of serious allergy such as anaphylaxis, angioedema and bronchospasm, or any serious reactions to any systemic antibacterial, which is allowed per protocol.
Refusal to give informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main outcome variable will be 30-day all-cause mortality, defined as the occurrence of death within 30 days from the index blood culture. |
The main outcome variable will be 30-day all-cause mortality, defined as the occurrence of death within 30 days from the index blood culture. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will be clinical and microbiological response at 7 days, clinical failure at day 14 and length of ICU and hospital stay (LOS) after the BSI episode. Secondary outcome would also include investigation of the independent risk factors for mortality in MBL producing Enterobacteriaceae, in the entire cohort. |
Day 7 and Day 14 |
|
|
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)
|
16/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This observational cohort study aims to assess the 30-day all-cause mortality in patients with bloodstream infections (BSIs) caused by MBL-producing Enterobacteriaceae, comparing outcomes between those treated with CAZ-AVI + ATM and those receiving other active antimicrobial regimens. The study will also evaluate independent risk factors associated with mortality in MBL-producing Enterobacteriaceae. |