Comparing the efficacy of two antibiotic groups for gram negative sepsis in intensive care unit

Comparing the efficacy of ceftazidime avibactum plus aztreonam therapy versus meropenem polymyxin combination therapy for gram negative sepsis by metallo-beta-lactamase producers in intensive care unit:A randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065863

Enrollment

Registered

2024-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: R99- Ill-defined and unknown cause of mortality Health Condition 2: I958- Other hypotension Health Condition 3: B998- Other infectious disease Health Condition 4: J17- Pneumonia in diseases classified elsewhere Health Condition 5: R579- Shock, unspecified

Interventions

Intervention1: Ceftazidime avibactam plus aztreonam: Ceftazidime-avibactum to be administered at the dose of 2.5 g every 8 hour and aztreonam at the dose of 2 g every 8 hours. Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: patients giving consent and age more than 18 years and culture positive for MBL.

Exclusion criteria

Exclusion criteria: The patient/relatives who refuse to give informed consent and Age less than 18 years and Patients having gram negative infections caused by CRAB/Non MBL and Pregnant females and Moribund and Brain dead patients and Patients with known allergy to given drug regime.

Design outcomes

Primary

Measure	Time frame
primary outcome is To compare the cure rate among two groups by culture negative report. Timepoint: 6 months	—

Secondary

Measure	Time frame
The secondary objectives will be To observe the Procalcitonin (PCT) and Proadrenomedullin levels in both the groups. To compare the neutrophil to lymphocyte ratio(NLR) in both the groups.To determine the length of ICU stay in both groups.To find out the 28-day all-cause mortality in both groups Timepoint: 6 months	—

Countries

India

Contacts

Public ContactTrishita Saha

All India Institute of Medical Sciences, Jodhpur

nikhilkothari729@gmail.com8369329852

Outcome results

None listed

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