Spontaneous Bacterial Peritonitis
Conditions
Brief summary
SBP is a common complication of cirrhotics with associated increased mortality. After first episode of SBP there is increased risk of again developing SBP, with increased chance of developing resistant organism. So after the first episode of SBP, prophylaxis for prevention of second episode onwards is mandatory and therefore Rifaximin or Norfloxacin is considered. It has been seen that apart from preventing SBP they have other benefits with negligible side effects and therefore it is to be seen what other benefits including mortality benefits these drugs can confer.
Detailed description
Hypothesis:-Rifaximin will be more effective in decreasing the incidence of SBP in patients with cirrhosis and prior episode of SBP AIM:-.To study the efficacy and safety of Rifaximin vs Norfloxacin in preventing incident SBP, preventing non-SBP infections, and improving transplant free survival in patients with cirrhosis and previous episode of SBP Methodology Single centered Open labeled Randomized Controlled Trial Randomization will be done by block randomization method taking block size as 10. Data will be entered in Microsoft Excel and will be analysed by SPSS Version 28.Categorical Data will be represented as frequency (%) and will be analysed using Chi square or Fisher Exact Test as appropriate.Continuous Data will be represented as Mean +/- SD and compared using Student T test or Mann Whitney as per normality conditions are met or not.Beside this an appropriate analysis like survival analysis will be carried out at the time of Data Analysis.P value \<0.05 will be considered as significant. Rescue therapy: To be given to patients who develop SBP while on secondary prophylaxis, these patients will initially be treated by iv medication in hospital settings followed by change in therapy. * Patients in Rifaximin limb developing SBP will switch to Norfloxacin * Patients in Norfloxacin limb developing SBP will switch to Rifaximin Treatment Failure: Defined as development of SBP at end of 6 months or 1 year of treatment. Study population: age \>18 years with prior incident SBP Study design: Randomised case controlled trial Study period: 1year after ethical clearance Sample size: 280 (140 in each arm) Intervention: This RCT will be conducted at ILBS New Delhi Monitoring and assessment: Monitoring will be done forall the parameters of the objective. Documentation will be done for any adverse effects which will happen. STATISTICAL ANALYSIS: Assuming incidence of SBP over 6 months is 4% in Rifaximin & 15% in Norfloxacin Alpha 5% and power 80%. Enrollment of 260 cases (130 in each arm). Assuming dropout rate 10%.Total study cases calculated as 280 (140 in each arm). Random allocation in each arm by block method taking 10 as block size
Interventions
DRUGRifaximin
Rifaximin 550 mg BD
DRUGNorfloxacin
Norfloxacin 400 mg OD
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\>18 years 2. Cirrhosis (of any etiology) with ascites 3. Prior incident SBP
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 (\<6 months) abdominal surgery 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 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of other site infections within 6 months | 6 months |
| Incidence of other site infections within 12 months | 12 months |
| to look for resistance pattern of infection in both norfloxacin and rifampicin group, type of resistant bacteria (MDR/XDR), and response of both groups to rifampicin and norfloxacin in secondary prophylaxis of SBP | 12 months |
| Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 months | 6 months |
| Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 12 months) | 12 months |
| Transplant free survival by 6 months | 6 months |
| Transplant free survival by 12 months | 12 months |
| Incidence of recurrence of SBP within12 months | 12 months |
| Change in Model for End-Stage Liver Disease (MELD) scores by 6 months | 6 months |
| Change in Model for End-Stage Liver Disease Sodium (MELD Na) scores by 6 months | 6 months |
| Change in Child-Turcotte-Pugh (CTP) scores by 12 months | 12 months |
| Change in Model for End-Stage Liver Disease (MELD) scores by 12 months | 12 months |
| Change in MELD-Na scores by 12 months | 12 months |
| Side effects in both groups | 12 months |
| Change in Child-Turcotte-Pugh (CTP) by 6 months | 6 months |
Countries
India
Contacts
Primary ContactDr Jayashree Biswas, MD
Outcome results
None listed