Primary prophylaxis with ciprofloxacin improves survival and reduces bacterial infections in patients with cirrhosis and ascites

ISRCTN	ISRCTN25761503
DOI	https://doi.org/10.1186/ISRCTN25761503
Protocol serial number	01/3045
Sponsor	The Health Council of Investigation of the Government of Buenos Aires (Argentina)
Funder	The Health Council of Investigation of the Government of Buenos Aires (Argentina) (ref: 01/3045)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ruben Terg
Scientific

Caseros 2061
Buenos Aires
1264
Argentina

Primary study design	Interventional
Study design	Multicentre, randomised, double blind, placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title	Primary prophylaxis with ciprofloxacin improves survival and reduces bacterial infections in patients with cirrhosis and ascites
Study acronym	SBP - Spontaneous Bacterial Peritonitis
Study objectives	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(s)	The protocol was approved by local ethic committees (ethics committee of Hospital Bonorino Udaondo and Hospital Alejandro Posadas) on the 6th March 2000.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ciprofloxacin
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	To assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of other infections and mortality.
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	100
Total final enrolment	100
Key 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
Key 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
Date of first enrolment	01/03/2000
Date of final enrolment	01/12/2005

Caseros 2061

Buenos Aires
1264
Argentina

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008	09/05/2019	Yes	No

09/05/2019: Publication reference and total final enrolment added.