Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

Cirrhosis Clinical Trial

Official title:

Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359853
• Other study ID #: 00-pbe-mnjf-2
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2006
• Last updated: August 1, 2006
• Start date: September 2000
• Est. completion date: March 2005

Study information

• Verified date: June 2004
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Advanced liver disease and low ascitic fluid protein concentration have been identified as risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and improves survival in cirrhotic patients with ascites and low protein concentration in ascitic fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130 mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods: Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral norfloxacin (400 mg/d; n=35) with placebo (n=35).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years, protein concentration in ascitic fluid < 15 g/L and at least one of the following: serum creatinine = 1.2 mg/dl or BUN = 25 mg/dl, serum sodium = 130 mEq/L or severe liver failure as defined by a Child-Pugh score = 9 points and a serum bilirubin = 3 mg/dl.

Exclusion Criteria:

• Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis, allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Hepatorenal Syndrome
• Liver Cirrhosis
• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Drug:
• Oral norfloxacin

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term and long-term survival
Secondary	Prevention of the first episode of spontaneous bacterial peritonitis
Secondary	Prevention of hepatorenal syndrome