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Norfloxacin Therapy for Patients With Cirrhosis and Severe Liver Failure

NCT01037959 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2015-12-09

No results posted yet for this study

Summary

Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that this translocation may worsen the underlying liver disease. Thus, the aim of this trial was to assess the effects of the oral administration of norfloxacin (an antibiotic that suppresses intestinal Gram-negative bacteria) on the development of complications of cirrhosis.

Conditions

  • Cirrhosis

Interventions

DRUG

Norfloxacin

400 mg/day (per os) for 6 months

DRUG

Placebo

1 pill/day (per os) for 6 months

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • MOREAU RICHARD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-11-30
Completion
2015-11-30

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT01037959 on ClinicalTrials.gov