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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN25761503

Enrollment

100

Registered

2007-02-09

Start date

2000-03-01

Completion date

Unknown

Last updated

2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhotic patients with ascites Digestive System Cirrhosis

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Argentina

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026