Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359853
Status:
COMPLETED
Last Update Posted:
2006-08-03
First Post:
2006-08-01
Brief Title:
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis
Status:
COMPLETED
Status Verified Date:
2004-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 gL and at least one of the following inclusion criteria functional renal failure serum creatinine 12 mgdl or BUN 25 mgdl hyponatremia serum sodium 130 mEqL or advanced liver disease Child 9 points with serum bilirubin 3 mgdl Methods Prospective multicenter randomized double-blind placebo controlled trial comparing oral norfloxacin 400 mgd n35 with placebo n35
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None