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.

Phase 3

Conditions: Health Condition 1: B998- Other infectious disease

Registration Number: CTRI/2023/05/052687

Lead Sponsor: AIIMS, Newdelhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average SOFA score over seven days following randomisation.Timepoint: Assessed at day 7 after randomisation

Secondary Outcome Measures

Name	Time	Method
(1)Progression to septic shock <br/ ><br>(2)All-cause mortality at 30 days after randomisation <br/ ><br>(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) <br/ ><br>(4)Time to taken to achieve clinical success <br/ ><br>(5)Microbiologic success <br/ ><br>(6)Infection relapse, <br/ ><br>(7)Secondary infection with a CRE and PA <br/ ><br>(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 <br/ ><br>(9Timepoint: 30days