Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
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ClinicalTrials.gov Identifier: NCT00359853 |
Recruitment Status :
Completed
First Posted : August 3, 2006
Last Update Posted : August 3, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spontaneous Bacterial Peritonitis Hepatorenal Syndrome Cirrhosis | Drug: Oral norfloxacin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis |
Study Start Date : | September 2000 |
Study Completion Date : | March 2005 |

- Short-term and long-term survival
- Prevention of the first episode of spontaneous bacterial peritonitis
- Prevention of hepatorenal syndrome

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359853
Spain | |
Hospital Clinic Barcelona | |
Barcelona, Catalonia, Spain, 08036 |
Principal Investigator: | Miquel Navasa, MD | Liver Unit. Hospital Clinic Barcelona |
ClinicalTrials.gov Identifier: | NCT00359853 |
Other Study ID Numbers: |
00-pbe-mnjf-2 |
First Posted: | August 3, 2006 Key Record Dates |
Last Update Posted: | August 3, 2006 |
Last Verified: | June 2004 |
Norfloxacin, primary prophylaxis, SBP |
Peritonitis Liver Cirrhosis Hepatorenal Syndrome Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases Intraabdominal Infections Infection Peritoneal Diseases Kidney Diseases |
Urologic Diseases Norfloxacin Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |