Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00359853
First received: August 1, 2006
Last updated: NA
Last verified: June 2004
History: No changes posted

August 1, 2006
August 1, 2006
September 2000
Not Provided
Short-term and long-term survival
Same as current
No Changes Posted
  • Prevention of the first episode of spontaneous bacterial peritonitis
  • Prevention of hepatorenal syndrome
Same as current
Not Provided
Not Provided
 
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Spontaneous Bacterial Peritonitis
  • Hepatorenal Syndrome
  • Cirrhosis
Drug: Oral norfloxacin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2005
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00359853
00-pbe-mnjf-2
Not Provided
Not Provided
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Miquel Navasa, MD Liver Unit. Hospital Clinic Barcelona
Hospital Clinic of Barcelona
June 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP