Contact information
Type
Scientific
Primary contact
Dr Miguel Navasa
ORCID ID
Contact details
Hospital Clinic
Liver Unit
Villarroel 170
Barcelona
00036
Spain
+34 (0)932 275 400 or 2 344
mnavasa@clinic.ub.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
99-PBE-MNJF-1
Study information
Scientific title
Acronym
MNJF1
Study hypothesis
Intravenous ceftriaxone is more effective than oral norfloxacin in reducing the rate of bacterial infections in patients with advanced cirrhosis and upper gastrointestinal bleeding.
Ethics approval
The study was approved by the Ethical Committee of each hospital participating in the study and by the Spanish Drug Agency on 29/12/1999
Study design
Randomised, unblinded, multicentre, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Advanced cirrhosis and haemorrhage
Intervention
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
2. Patients in the second group received intravenous ceftriaxone 1 g per day for seven days
Antibiotics were initiated following the emergency endoscopy and always within the first 12 hours after admission into the hospital. Randomisation was done using consecutively numbered computer-generated envelopes containing treatment assignment. Randomisation was independent at each hospital.
Intervention type
Drug
Phase
Not Specified
Drug names
Oral norfloxacin, intravenous ceftriaxone
Primary outcome measures
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 outcome measures
To assess the effects of treatment allocation on control bleeding and hospital survival.
Overall trial start date
01/02/2000
Overall trial end date
30/04/2004
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
122
Participant 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
Recruitment start date
01/02/2000
Recruitment end date
30/04/2004
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Clinic
Barcelona
00036
Spain
Sponsor information
Organisation
Barcelona Hospital Clinic Villarroel (Spain)
Sponsor details
c/o Vincent Arroyo
Hospital Clinic
Liver Unit
Barcelona
08036
Spain
+34 (0)932 275 400
varroyo@clinic.ub.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Barcelona Hospital Clinic Villarroel (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary