Study Stopped
lack of recruitement
Norfloxacin Therapy for Patients With Cirrhosis and Severe Liver Failure
NORFLOCIR
Randomized, Double-Blind, Placebo-Controlled Trial Assessing Norfloxacin in the Prevention of Complications in Patients With Cirrhosis and Severe Liver Failure
1 other identifier
interventional
291
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 9, 2015
November 1, 2015
4.6 years
December 21, 2009
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate
6 months
Secondary Outcomes (3)
Survival rate
12-month follow-up
Number of patient with liver transplantation
12 months
Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding
12 months
Study Arms (2)
Norfloxacin
ACTIVE COMPARATORPatients with severe cirrhosis treated with norfloxacin
Placebo
PLACEBO COMPARATORPatients with severe cirrhosis treated with placebo
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years,
- Liver failure as defined by a Child-Pugh score ≥ 10 points,
- Accept to participate,
- Have health insurance.
You may not qualify if:
- Pregnancy,
- Allergy to quinolones,
- Hepatocellular carcinoma, and
- HIV infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assisatnce publique Hoptitaux de Paris
Clichy, 92110, France
Related Publications (1)
Moreau R, Elkrief L, Bureau C, Perarnau JM, Thevenot T, Saliba F, Louvet A, Nahon P, Lannes A, Anty R, Hillaire S, Pasquet B, Ozenne V, Rudler M, Ollivier-Hourmand I, Robic MA, d'Alteroche L, Di Martino V, Ripault MP, Pauwels A, Grange JD, Carbonell N, Bronowicki JP, Payance A, Rautou PE, Valla D, Gault N, Lebrec D; NORFLOCIR Trial Investigators. Effects of Long-term Norfloxacin Therapy in Patients With Advanced Cirrhosis. Gastroenterology. 2018 Dec;155(6):1816-1827.e9. doi: 10.1053/j.gastro.2018.08.026. Epub 2018 Aug 23.
PMID: 30144431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MOREAU RICHARD
APHP
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2009
First Posted
December 23, 2009
Study Start
April 1, 2010
Primary Completion
November 1, 2014
Study Completion
November 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-11