Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis

• Status: Active, not recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

Background

Prophylaxis of SBP is indicated in three high-risk populations: patients with acute gastrointestinal hemorrhage, patients with low total protein content in ascitic fluid, and patients with a previous history of SBP (secondary prophylaxis).

Selective intestinal decontamination with norfloxacin, a quinolone with relatively poor gastrointestinal absorption and with antibacterial activity against GNB, is the most commonly used regimen, but several concerns have been recently raised in this regard.

A recent network meta-analysis published by the investigators showed that rifaximin determines interesting results in this setting but needs to be tested in further trials.

Given its favorable safety profile and the relatively low cost, rifaximin could represent the antibiotic of choice in long-term prophylaxis.

Study Objective To establish the prophylactic efficacy, of rifaximin as compared to norfloxacin in cirrhotic patients with low protein content in the ascitic fluid.

Protocol design Phase III, two-arms, open-label, multi-center, randomized controlled trial.

Trial population Patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 milliequivalent [mEq]/L)

Protocol Treatments

• The Treatment arm will undergo rifaximin 1200 mg/day in 3 doses.

• The Control arm will undergo norfloxacin 400 mg 1/die for 6 months

Primary Endpoint Prevention of spontaneous bacterial peritonitis episodes.

Secondary Endpoints

• Prevention of mortality (both all-cause and liver-related mortality)

• Preventions of hepatorenal syndrome

• Prevention of other infections

• Adverse events

Sample size and study duration It will be planned to enroll 322 patients (161 per arms) within 18 months. A minimum follow up of 6 months from the last patient recruited will be required.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedali Riuniti di Foggia
• Treatments: Norfloxacin; Rifaximin

Criteria

Inclusion Criteria:

• Adult patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L)

Exclusion Criteria:

• Age under 18 years

• Previous history of SBP

• Previous use of antibiotics within the previous two weeks

• Previous GIT bleeding within one month

• Resolving ascites for one month after diuretic therapy

• Liver malignancy, organic renal disease

• Human immunodeficiency virus infection

• Known hypersensitivity to planned drugs

• Refusal to provide informed consent.