Randomized, Double-Blind, Placebo-Controlled Trial Assessing Norfloxacin in the Prevention of Complications in Patients With Cirrhosis and Severe Liver Failure (NORFLOCIR)

NCT01037959 Phase 3 TERMINATED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	TERMINATED
Enrolment	291
Start date	2010-04
Completion	2015-11

Conditions

• Cirrhosis

Interventions

• Norfloxacin
• Placebo

Primary outcomes

• Survival rate — 6 months

Countries

France