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Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis

NCT04159870 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2021-02-16

No results posted yet for this study

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.

Conditions

  • Spontaneous Bacterial Peritonitis

Interventions

DRUG

Rifaximin

Rifaximin pills 400 mg x 3/day

DRUG

Norfloxacin

Norlfloxacin 400 mg 1 pill/day

Sponsors & Collaborators

  • Ospedali Riuniti di Foggia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2021-11-20
Completion
2021-12-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159870 on ClinicalTrials.gov