Condition category
Digestive System
Date applied
31/01/2006
Date assigned
30/03/2006
Last edited
20/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes