Health Condition 1: K720- Acute and subacute hepatic failure
Conditions
Interventions
Intervention1: Ceftazidime avibactam: Ceftazidime avibactam 2.5 gm intravenous TDS. Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD.
Duration:7 days
Control Intervention1: Meropenem: Meropenem 2
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years 2. ACLF as per APASL criteria 3. ACLF patients with nosocomial infections caused by carbapenem resistant organism (defined as suspected or documented evidence of infection after 48 hours of hospitalization) requiring antibiotics
Exclusion criteria
Exclusion criteria: 1. Severe septic shock with MOF requiring escalation of antibiotics 2. Patients having known allergies to meropenem or Ceftazidime Avibactam 3. Culture sensitivity showing isolate non susceptible to study drug being investigated. 4. Already on either regimen, receiving meropenem or Ceftazidime Avibactam for more than 48 hours. 5. On mechanical ventilator support PF for less than 300. 6. Patients on immunosuppression medication 7. HCC or other malignancies 8. CKD 9. CAD 10. Pregnancy or Lactation 11. Post Liver Transplantation 12. Refusal to consent 13. PLWHA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of ACLF patients with nosocomial infection by carbapenem resistant organisms showing clinical response at the end of treatmentTimepoint: 3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to escalation of antibioticsTimepoint: day 5;Progression in terms of organ dysfunction/failure at day 5 and 7.Timepoint: day 5 & 7;Incidence of adverse events in both groupsTimepoint: day 28;Duration of hospital and ICU stayTimepoint: day 28;Mortality at day 15 and day 28Timepoint: day 15 and day 28 | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed