Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis
Status:
Active, not recruiting
Trial end date:
2021-12-20
Target enrollment:
Participant gender:
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.