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

Not Applicable

Completed

• Conditions: Advanced cirrhosis and haemorrhage; Digestive System; Liver cirrhosis

• Registration Number: ISRCTN52008589
• Lead Sponsor: Barcelona Hospital Clinic Villarroel (Spain)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-04-30
• Study Start: 2006-03-30
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified