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

Phase 4

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

• Registration Number: CTRI/2024/08/071797
• Lead Sponsor: All India Institute Of Medical Sciences, New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to evaluate the <br/ ><br>clinical response of pneumonia resolution in two groups after 14 days of antibiotic <br/ ><br>therapy for carbapenem resistant acinetobacter baumannii <br/ ><br>ventilator associated pneumonia.Timepoint: evaluate the <br/ ><br>clinical response in two groups after 14 days of antibiotic <br/ ><br>therapy for pneumonia.

Secondary Outcome Measures

Name	Time	Method
1. VAP related mortality during the 14 day period of antibiotic therapy <br/ ><br>2. Microbiological eradication of acinetobacter baumannii from tracheal aspirate sampling done prior to extubation or at the end of 14 day therapy <br/ ><br>3. Clinical outcomes in terms of SOFA score at day 5 and at day 14 of antibiotic therapy <br/ ><br>4. Number of days the patient is on ventilator after initiation of antibiotic therapy <br/ ><br>5. ICU length of stay after initiation of antibiotic therapy <br/ ><br>6. 28 day mortality after initiation of antibiotic therapy <br/ ><br>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