Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Rifaximin: Rifaximin 550 mg BD
Duration: 1 year
Route: Oral
Control Intervention1: Norfloxacin: Norfloxacin 400 mg OD
Duration: 1 year
Route: Oral
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age >18 years 2) Cirrhosis (of any etiology) with ascites 3) Prior incident SBP
Exclusion criteria
Exclusion criteria: 1. Allergy to norfloxacin or rifaximin 2. Recent history of upper gastrointestinal bleed (UGIB) within 2 weeks 3. Patients with a history of multiple episodes of SBP 4. Patients with inoperable or not treatable HCC or other non-hepatic malignancy 5. Patients on immunosuppression 6. HIV infected 7. Post liver transplant 8. Recent ( 9. Pregnant/lactating women 10. Other causes of ascites like tubercular or malignancy 11. Patients developing SBP on Norfloxcacin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of recurrence of SBP within 6 monthsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in gut microbiome in both groups by 6 and 12 monthsTimepoint: 6 months and 12 months;Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 and 12 months)Timepoint: 6 and 12 months;Incidence of other site infections within 6 and 12 monthsTimepoint: 6 and 12 months;Incidence of recurrence of SBP within12 monthsTimepoint: 12 months;Median change in CTP, MELD, MELD-Na scores by 6 months and 12 monthsTimepoint: 6 months and 12 months;Resistance patterns of infections in each groupTimepoint: 12 months;Side effects in both groupsTimepoint: 12 months;Transplant free survival by 6 and 12 monthsTimepoint: 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sharma
Institute of Liver and Biliary Sciences
Outcome results
None listed