Health Condition 1: B962- Escherichia coli [E. coli ] as thecause of diseases classified elsewhere Health Condition 2: B961- Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere Health Condition 3: B965- Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
FMRI
Eligibility
Inclusion criteria
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 -White blood cell count >11,000 or 15% band forms
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical success with respect to following: 1.Fever 2.TLC 3. Patient alive 4.Systolic blood pressure 90 mmHg without need for vasopressor support 5.Stable or improved SOFA score 6. For patients with HAP/ VAP, PaO2/FiO2 ratio stable or improved 7. For patients with bacteraemia, no growth of the initial isolate in blood cultures taken on day 14 if patient still febrileTimepoint: Day 1- ie on day of culture positivity Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the 28-day mortalityTimepoint: Day 28 of Culture positivity | — |
Countries
India
Contacts
Public ContactDivya Gupta
Fortis Memorial Research Institute, Gurgaon
Outcome results
None listed