Comparison of two combination of antibiotics for Extensively drug resistant Gram Negative Bacteria in ICU patients

Phase 4

• Conditions: Health Condition 1: B962- Escherichia coli [E. coli ] as thecause of diseases classified elsewhereHealth Condition 2: B961- Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhereHealth Condition 3: B965- Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/03/024343
• Lead Sponsor: FMRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Any body-fluid culture positive for gram negative Enterobacteriaceae

2. Sensitive to only one or two group of antibiotics (carbapenem resistant)

3. Onset of symptoms >=48 hours after admission to hospital or history of hospital admission in past 30 days

4.>=1 systemic sign of infection

-Fever (temperature >38°C) or hypothermia (temperature <35°C)

-White blood cell count >11,000 or <4000 cells/mm3, or >15% band forms

Exclusion Criteria

1.On triple/multi drug therapy for GNB

2.Patient refusal to participate in the study

3.Follow up drop outs

4.Need to change to other drugs during the study

5.Known allergy to study drugs

6.Previous inclusion in the study

7.Polymicrobial infection where one or more of the clinically-significant gram-negative bacteria are susceptible to any beta-lactam

8.Pregnant patients.

Study & Design

• Study Type: Observational
• Study Design: Not specified