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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52008589
Enrollment
122
Registered
2006-03-30
Start date
2000-02-01
Completion date
Unknown
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced cirrhosis and haemorrhage Digestive System Liver cirrhosis

Interventions

Patients who fulfilled the inclusion criteria were randomly allocated into two groups: 1. Patients in the first group received oral norfloxacin 400 mg every 12 hours for seven days

Sponsors

Barcelona Hospital Clinic Villarroel (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The end point of the study was to assess if intravenous ceftriaxone is more effective than oral norfloxacin in reducing the rate of bacterial infections within the first 10 days after the haemorrhage.

Secondary

MeasureTime frame
To assess the effects of treatment allocation on control bleeding and hospital survival.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026