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
| ISRCTN | ISRCTN52008589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52008589 |
| Secondary identifying numbers | 99-PBE-MNJF-1 |
- Submission date
- 31/01/2006
- Registration date
- 30/03/2006
- Last edited
- 01/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Miguel Navasa
Scientific
Scientific
Hospital Clinic
Liver Unit
Villarroel 170
Barcelona
00036
Spain
| Phone | +34 (0)932 275 400 or 2 344 |
|---|---|
| mnavasa@clinic.ub.es |
Study information
| Study design | Randomised, unblinded, multicentre, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | 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 |
| Study acronym | MNJF1 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral norfloxacin, intravenous ceftriaxone |
| Primary outcome measure | 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 study start date | 01/02/2000 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 122 |
| Total final enrolment | 111 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/02/2000 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Clinic
Barcelona
00036
Spain
00036
Spain
Sponsor information
Barcelona Hospital Clinic Villarroel (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Vincent Arroyo
Hospital Clinic
Liver Unit
Barcelona
08036
Spain
| Phone | +34 (0)932 275 400 |
|---|---|
| varroyo@clinic.ub.es | |
"ROR" |
https://ror.org/02a2kzf50 |
Funders
Funder type
Hospital/treatment centre
Barcelona Hospital Clinic Villarroel (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2006 | 01/09/2021 | Yes | No |
Editorial Notes
01/09/2021: Publication reference and total final enrolment added.
