Comparison of 2 strategies of antibiotic therapy with Polymyxin group vs Ceftazidime avibactam and Aztreonam for treatment of infections with multi drug resistant gram negative bacteria.

POLYMYXIN vs. CEFTAZIDIME-AVIBACTAM with AZTREONAM for primary treatment of Carbapenem Resistant Enterobacteriaceae (CRE) and Carbapenem Resistant Pseudomonas aeruginosa (CRPA) - CARE

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052687

Enrollment

Registered

2023-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B998- Other infectious disease

Interventions

Intervention1: Combination of ceftazidime avibactam and aztreonam Ceftazidime avibactam Dose- 2.5g eighth hourly Duration- 7days Aztreonam Dose: 2g eighth hourly Duration: 7 days: Ceftazidime av

Eligibility

Inclusion criteria

Inclusion criteria: 2. Sepsis (as per Sepsis-3 definition) 3. CRE/PA detected on blood culture (Bact T Alert), followed by Malditof ID 4. Carbapenemase gene positive PCR assay.

Exclusion criteria

Exclusion criteria: 1. Refusal of consent 2. Colistin resistance gene positive on PCR assay 3. Patient not expected to survive more than 4 days (decided clinically) 4. Patients on significant vasopressor support at the time of enrolment (defined as noradrenaline requirement more than 0.1 mcg/kg/min) 5. Patient allergic to either of the drugs in the control or intervention group 6. Patient with significant polymicrobial infection [coinfection with two different CRE, or CRE and CRPA, or CRE/CRPA and Acinetobacter Baumannii/gram positive bacteria (Gram positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia)]. 7. Pregnancy or breast feeding 8. Significant pre-existing comorbidities – CKD 4/5, CLD 9. Patients already receiving either CAZ-AVI/ATM or polymyxins prior to enrolment

Design outcomes

Primary

Measure	Time frame
Average SOFA score over seven days following randomisation.Timepoint: Assessed at day 7 after randomisation	—

Secondary

Measure	Time frame
(1) Progression to septic shock (2) All-cause mortality at 30 days after randomisation (3) Rate of clinical success (without cross-over), defined as absence of shock, fever (temperature 38.0°C), leucocytosis (white blood cell count 12 000/ml) and leucopoenia (white blood cell count 4000/ml) (4) Time to taken to achieve clinical success (5) Microbiologic success (6) Infection relapse, (7) Secondary infection with a CRE and PA (8) Need for cross-over or escalation, defined as lack of clinical improvement or clinical worsening that mandates initiation of alternative regimen along with the primary antibiotic therapy (9Timepoint: 30days	—

Measure

Time frame

(1) Progression to septic shock (2) All-cause mortality at 30 days after randomisation (3) Rate of clinical success (without cross-over), defined as absence of shock, fever (temperature 38.0°C), leucocytosis (white blood cell count 12 000/ml) and leucopoenia (white blood cell count 4000/ml) (4) Time to taken to achieve clinical success (5) Microbiologic success (6) Infection relapse, (7) Secondary infection with a CRE and PA (8) Need for cross-over or escalation, defined as lack of clinical improvement or clinical worsening that mandates initiation of alternative regimen along with the primary antibiotic therapy (9Timepoint: 30days

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Countries

India

Contacts

Public ContactPriyankar Datta

AIIMS,ND

drrajathadri@gmail.com9886936414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026