Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159870
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Facciorusso, Ospedali Riuniti di Foggia

Brief 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.


Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Drug: Rifaximin Drug: Norfloxacin Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Intervention Group
Rifaximin 1200 mg/day in 3 doses
Drug: Rifaximin
Rifaximin pills 400 mg x 3/day

Active Comparator: Control Group
Norfloxacin 400 mg/day in one dose
Drug: Norfloxacin
Norlfloxacin 400 mg 1 pill/day




Primary Outcome Measures :
  1. Prevention of Spontaneous Bacterial Peritonitis [ Time Frame: 6 months ]
    Rate of episodes of spontaneous bacterial peritonitis


Secondary Outcome Measures :
  1. Prevention of mortality [ Time Frame: 6 months ]
    Rate of deaths observed

  2. Prevention of hepatorenal syndrome [ Time Frame: 6 months ]
    Rate of hepatorenal syndrome episodes

  3. Prevention of other infections [ Time Frame: 6 months ]
    Rate of other infections

  4. Adverse Events [ Time Frame: 6 months ]
    Rate of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Antonio Facciorusso, MD PhD 0881732015 antonio.facciorusso@virgilio.it
Contact: Rodolfo Sacco, MD PhD 0881732015 r.sacco@ao-pisa.toscana.it

Locations
Layout table for location information
Italy
Ospedale di Andria Recruiting
Andria, Italy, 71122
Contact: Nicola Minerva, MD    0881732015      
Ospedali Riuniti Foggia Recruiting
Foggia, Italy, 71122
Contact: Antonio Facciorusso, MD    0881732015    antonio.facciorusso@virgilio.it   
Ospedale di Lucca Recruiting
Lucca, Italy, 71122
Contact: Sauro Luchi, MD    0881732015      
Sponsors and Collaborators
Ospedali Riuniti di Foggia
Publications of Results:

Layout table for additonal information
Responsible Party: Antonio Facciorusso, Principal Investigator, Ospedali Riuniti di Foggia
ClinicalTrials.gov Identifier: NCT04159870    
Other Study ID Numbers: RIFA01
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Rifaximin
Norfloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors