Condition category
Digestive System
Date applied
19/01/2007
Date assigned
09/02/2007
Last edited
09/02/2007
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 Ruben Terg

ORCID ID

Contact details

Caseros 2061
Buenos Aires
1264
Argentina

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/3045

Study information

Scientific title

Acronym

SBP - Spontaneous Bacterial Peritonitis

Study hypothesis

The aim of the present study was to assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of Spontaneous Bacterial Peritonitis (SBP) in patients with cirrhosis and low protein concentration in ascitic fluid.

Ethics approval

The protocol was approved by local ethic committees (ethics committee of Hospital Bonorino Udaondo and Hospital Alejandro Posadas) on the 6th March 2000.

Study design

Multicentre, randomised, double blind, placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cirrhotic patients with ascites

Intervention

Ciprofloxacin 500 mg a day or placebo, oral, during 12 months for intervention group and the control group.

Intervention type

Drug

Phase

Not Specified

Drug names

Ciprofloxacin

Primary outcome measures

To assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of SBP in patients with cirrhosis and low protein concentration in ascitic fluid.

Secondary outcome measures

To assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of other infections and mortality.

Overall trial start date

01/03/2000

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Diagnosis of cirrhosis was based in clinical, biochemical, ultrasonographic and histological criteria.

Inclusion criteria were:
1. Aged more than 18 and less than 80 years
2. Total protein in ascitic fluid less than 1.5 g/dl
3. Ability to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100 patients (50 in ciprofloxacin group and 50 in placebo group)

Participant exclusion criteria

1. A previous episode of SBP
2. Antibiotics in the previous 30 days
3. Pregnancy
4. Active gastrointestinal bleeding
5. Encephalopathy more than grade two
6. Hepatocarcinoma or other malignancies
7. Allergy to quinolones
8. Serum creatinine more than 3 mg/dl
9. Bacterial infection

Recruitment start date

01/03/2000

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Argentina

Trial participating centre

Caseros 2061
Buenos Aires
1264
Argentina

Sponsor information

Organisation

The Health Council of Investigation of the Government of Buenos Aires (Argentina)

Sponsor details

Medrano 350
Piso 2
Buenos Aires
1179
Argentina

Sponsor type

Government

Website

http://www.buenosaires.gov.ar/area/salud/cons_investigación

Funders

Funder type

Government

Funder name

The Health Council of Investigation of the Government of Buenos Aires (Argentina) (ref: 01/3045)

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