NCT02120196

Brief Summary

The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

9.9 years

First QC Date

April 7, 2014

Last Update Submit

January 5, 2018

Conditions

Spontaneous Bacterial PeritonitisAscitesLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with recurrence of SBP

    The total number of paper of participitants with recurrence of SBP

    6 months

Study Arms (2)

rifaximin

EXPERIMENTAL

Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.

Drug: Rifaximin

norfloxacin

ACTIVE COMPARATOR

Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.

Drug: Norfloxacin

Interventions

RifaximinDRUG

rifaximin 1200 mg daily versus norfloxacin 400 mg once daily

Also known as: Gastrobiotic, Trencedia
rifaximin
NorfloxacinDRUG

FDA approved:400mg once daily

Also known as: Epinor
norfloxacin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous episode of SBP
  • Total protein in the ascitic fluid below or equal to 1.5 g/dL

You may not qualify if:

  • Allergy to quinolones
  • Recent ( within the previous 2 weeks) episode of digestive hemorrhage
  • Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

AscitesLiver Cirrhosis

Interventions

RifaximinNorfloxacin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesFibrosis

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Asem A Elfert

    TUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief M. Abd-Elsalam, Lecturer

CONTACT

00201000040794Sheif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 22, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)