Randomised, multicentre, controlled trial comparing oral norfloxacin versus intravenous ceftriaxone in the prevention of bacterial infections in cirrhotic patients with severe liver failure and gastrointestinal bleeding

Barcelona Hospital Clinic Villarroel (Spain)0 sites111 target enrollmentMarch 30, 2006

Overview

2006 Results article in https://pubmed.ncbi.nlm.nih.gov/17030175/ (added 01/09/2021)

Registry

who.int

Start Date

March 30, 2006

End Date

April 30, 2004

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Barcelona Hospital Clinic Villarroel (Spain)

•1\. Age 18 \- 80 years
•2\. Haematemesis and/or melena within 24 hours prior to inclusion
•3\. Advanced cirrhosis as defined by the presence of two or more of the following signs of liver failure:
•3\.1\. Severe malnutrition
•3\.2\. Serum bilirubin greater than 3 mg/dl
•3\.3\. Ascites and hepatic encephalopathy (grade 1 or more)

•1\. Allergy to cephalosporins or quinolones
•2\. Presence of any of the following signs of infection:
•2\.1\. Fever greater than 37\.5°C
•2\.2\. White blood cell count greater than 15,000 mm^3
•2\.3\. Immature neutrophils greater than 500 mm^3
•2\.4\. More than 15 leukocytes per field in the fresh urine sediment or data compatible with pneumonia on the chest x\-ray
•3\. Treatment with antibiotics within two weeks prior to the hemorrhage (excluding oral norfloxacin for prophylaxis of spontaneous bacterial peritonitis \[SBP])
•4\. Previously diagnosed advanced hepatocelullar carcinoma (one nodule greater than 5 cm, three nodules with one greater than 3 cm or more than three nodules) and human immunodeficiency virus (HIV) infection