Comparison of presently used antibiotics for treating patients who develop pneumonia while being on ventilator

Comparison of polymyxin-b with minocycline versus polymyxin-b with high dose sulbactam in carbapenem resistant acinetobacter baumannii ventilator associated pneumonia- a randomized double blind noninferiority study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071797

Enrollment

150

Registered

2024-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: J168- Pneumonia due to other specified infectious organisms

Interventions

Intervention1: Polymyxin and minocycline: Patients admitted to intensive care unit of AIIMS Delhi who are diagnosed to have microbiologically documented VAP from CRAB and susceptible to colistin and m

Eligibility

Inclusion criteria

Inclusion criteria: Admitted to the ICU and intubated for more than 48 hours with microbiologically documented VAP due to Acinetobacter baumannii resistant to carbapenems but susceptible to colistin and minocycline

Exclusion criteria

Exclusion criteria: 1. Patients on short term mechanical ventilation for less than 48 hours. 2. Patients receiving empirical antimicrobial treatment against gram-negative bacteria for longer than 72 h or if empirical treatment consisted of minocycline or sulbactam regimens. 3. Patients with a clinical diagnosis of VAP but without microbiological documentation as well as polymicrobial VAP. 4. Pregnant patients 5. Withdrawal of consent

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study is to evaluate the clinical response of pneumonia resolution in two groups after 14 days of antibiotic therapy for carbapenem resistant acinetobacter baumannii ventilator associated pneumonia.Timepoint: evaluate the clinical response in two groups after 14 days of antibiotic therapy for pneumonia.	—

Secondary

Measure	Time frame
1. VAP related mortality during the 14 day period of antibiotic therapy 2. Microbiological eradication of acinetobacter baumannii from tracheal aspirate sampling done prior to extubation or at the end of 14 day therapy 3. Clinical outcomes in terms of SOFA score at day 5 and at day 14 of antibiotic therapy 4. Number of days the patient is on ventilator after initiation of antibiotic therapy 5. ICU length of stay after initiation of antibiotic therapy 6. 28 day mortality after initiation of antibiotic therapy 7. Incidence of adverse events related to treatment such as incidence of acute kidney injury, anaphylaxis or worsening of liver enzymes.Timepoint: At day5 and at Day14 from start of antibiotic regimen	—

Measure

Time frame

1. VAP related mortality during the 14 day period of antibiotic therapy 2. Microbiological eradication of acinetobacter baumannii from tracheal aspirate sampling done prior to extubation or at the end of 14 day therapy 3. Clinical outcomes in terms of SOFA score at day 5 and at day 14 of antibiotic therapy 4. Number of days the patient is on ventilator after initiation of antibiotic therapy 5. ICU length of stay after initiation of antibiotic therapy 6. 28 day mortality after initiation of antibiotic therapy 7. Incidence of adverse events related to treatment such as incidence of acute kidney injury, anaphylaxis or worsening of liver enzymes.Timepoint: At day5 and at Day14 from start of antibiotic regimen

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Countries

India

Contacts

Public ContactCh Parimal Patel

AIIMS

drgpd@aiims.edu9182030551

Outcome results

None listed

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