Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis
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|ClinicalTrials.gov Identifier: NCT04159870|
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : February 16, 2021
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)
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Spontaneous Bacterial Peritonitis||Drug: Rifaximin Drug: Norfloxacin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||322 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rifaximin Versus Norfloxacin in the Primary Prophylaxis of Spontaneous Bacterial Peritonitis|
|Actual Study Start Date :||November 5, 2019|
|Estimated Primary Completion Date :||November 20, 2021|
|Estimated Study Completion Date :||December 20, 2021|
Experimental: Intervention Group
Rifaximin 1200 mg/day in 3 doses
Rifaximin pills 400 mg x 3/day
Active Comparator: Control Group
Norfloxacin 400 mg/day in one dose
Norlfloxacin 400 mg 1 pill/day
- Prevention of Spontaneous Bacterial Peritonitis [ Time Frame: 6 months ]Rate of episodes of spontaneous bacterial peritonitis
- Prevention of mortality [ Time Frame: 6 months ]Rate of deaths observed
- Prevention of hepatorenal syndrome [ Time Frame: 6 months ]Rate of hepatorenal syndrome episodes
- Prevention of other infections [ Time Frame: 6 months ]Rate of other infections
- Adverse Events [ Time Frame: 6 months ]Rate of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159870
|Ospedali Riuniti Foggia|
|Foggia, Italy, 71122|