comparison of three antibiotic combination with two antibiotic combination for treatment of lung infection in patients on ventilator

A randomised controlled trial of sulbactam based 3-drug vs 2-drug regimen for treatment of Carbapenem-Resistant Acinetobacter baumannii ventilator associated pneumonia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094280

Enrollment

126

Registered

2025-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: J156- Pneumonia due to other Gram-negative bacteria

Interventions

Intervention1: Group A :3 drug sulbactam based regimen: 1. Polymyxin B: Intravenous (IV) loading dose of 25,000 IU/kg actual body weight, followed by 12,500 IU/kg every 12 hours. 2. Sulbactam: 3 gm s

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed as Ventilator associated pneumonia as per CDC definition with tracheal aspirate/ BAL cultures positive for Carabapenem Resistant Acinetobacter Baumannii(CRAB) but susceptible to Polymyxin and Minocycline

Exclusion criteria

Exclusion criteria: 1. Refusal to participate or lack of written informed consent 2. Known allergies to study drugs 3. Pregnant patients and lactating mothers 4. Poly-microbial VAP 5. Patients not expected to survive beyond study period 6. Pulmonary disease that precludes evaluation of therapeutic response eg lung cancer/lung metastases/active tuberculosis 7. Patients already on RRT at the start of treatment

Design outcomes

Primary

Measure	Time frame
Clinical Cure Rate at Day 8: Defined as complete resolution of VAP symptoms and signs (e.g., normalized temperature, white blood cell count, oxygenation, and no purulent secretions) by Day 8 of treatment.Timepoint: Day 8 of treatment	—

Secondary

Measure	Time frame
Microbiological Eradication at Day 8: No growth of CRAB in respiratory samples (ETA or BAL) on Day 8 of treatment.Timepoint: Day 8 of treatment;Clinical Improvement at Day 8 of treatment : Partial resolution of VAP symptoms and signs (e.g., improved oxygenation, reduced fever, or purulent secretions)Timepoint: Day 8 of treatment;Clinical Failure rates : Persistence or worsening of VAP symptoms and signsTimepoint: Day 8 of treatment;ICU Length of Stay (LOS): Duration from randomization to ICU dischargeTimepoint: Time from randomization to ICU discharge;28-Day Mortality: All-cause mortality within 28 days from randomization.Timepoint: Day 28 after randomization;Incidence of Acute Kidney Injury (AKI)Timepoint: Day 8 of treatment	—

Measure

Time frame

Microbiological Eradication at Day 8: No growth of CRAB in respiratory samples (ETA or BAL) on Day 8 of treatment.Timepoint: Day 8 of treatment;Clinical Improvement at Day 8 of treatment : Partial resolution of VAP symptoms and signs (e.g., improved oxygenation, reduced fever, or purulent secretions)Timepoint: Day 8 of treatment;Clinical Failure rates : Persistence or worsening of VAP symptoms and signsTimepoint: Day 8 of treatment;ICU Length of Stay (LOS): Duration from randomization to ICU dischargeTimepoint: Time from randomization to ICU discharge;28-Day Mortality: All-cause mortality within 28 days from randomization.Timepoint: Day 28 after randomization;Incidence of Acute Kidney Injury (AKI)Timepoint: Day 8 of treatment

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Countries

India

Contacts

Public ContactDr Kelika prakash

AIIMS, NEW DELHI

kelika.prakash@gmail.com9540947117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026