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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR CEFOTAXIME SODIUM

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Clinical Trials for Cefotaxime Sodium

Trial ID Title Status Sponsor Phase Summary
NCT00570960 Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis Terminated American Association for the Study of Liver Diseases Phase 4 The core of the proposal is a prospective, randomized, double-blinded, controlled study which will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA approved for plasma volume expansion, is significantly less expensive than human albumin, this study is designed and powered to determine if dextran 70 is equivalent in clinical efficacy when compared to albumin. Specific aims for this project are to: 1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis compared to plasma volume expansion with human albumin. 2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic peptide, and further development of the hepatorenal syndrome in cirrhotic patients with spontaneous bacterial peritonitis. 3. Compare the survival to liver transplantation, treatment costs, hospitalization costs, resource utilization, and quality of life of patients with spontaneous bacterial peritonitis treated with dextran 70 and human albumin in the 30 days following diagnosis. 4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research. 5. Establish a clinical electronic database with web-based data entry and remote analysis capabilities linking tissue bank samples and patient outcomes related to the above clinical trials.
NCT00570960 Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis Terminated University of Virginia Phase 4 The core of the proposal is a prospective, randomized, double-blinded, controlled study which will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA approved for plasma volume expansion, is significantly less expensive than human albumin, this study is designed and powered to determine if dextran 70 is equivalent in clinical efficacy when compared to albumin. Specific aims for this project are to: 1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis compared to plasma volume expansion with human albumin. 2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic peptide, and further development of the hepatorenal syndrome in cirrhotic patients with spontaneous bacterial peritonitis. 3. Compare the survival to liver transplantation, treatment costs, hospitalization costs, resource utilization, and quality of life of patients with spontaneous bacterial peritonitis treated with dextran 70 and human albumin in the 30 days following diagnosis. 4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research. 5. Establish a clinical electronic database with web-based data entry and remote analysis capabilities linking tissue bank samples and patient outcomes related to the above clinical trials.
NCT00852800 Low-dose Albumin Solution in SBP: a Randomized Double-blind Pilot Study Enrolling by invitation Hospital de Clinicas de Porto Alegre Phase 2 Spontaneous bacterial peritonitis (SBP) is a common and severe complication of cirrhosis. The most serious complication of SBP is the hepatorenal syndrome (HRS), which occurs in up to 30 percent of patients, with high mortality. Intravenous albumin (1.5 g/kg at diagnosis and 1 g/kg 48 hours later - standard regimen) helps to prevent HRS and improves survival. No information exists on the efficacy of lower doses of albumin. This study was designed to allow direct comparison among different doses of intravenous albumin in patients with SBP - standard (SR) vs dose reduced regimen (DRR) - in order to prevent renal failure and mortality.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cefotaxime Sodium

Condition Name

Condition Name for Cefotaxime Sodium
Intervention Trials
Urinary Tract Infections 2
Respiratory Tract Infections 2
Renal Impairment 1
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Condition MeSH

Condition MeSH for Cefotaxime Sodium
Intervention Trials
Urinary Tract Infections 2
Respiratory Tract Infections 2
Infection 2
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Clinical Trial Locations for Cefotaxime Sodium

Trials by Country

Trials by Country for Cefotaxime Sodium
Location Trials
Brazil 2
United States 1
Egypt 1
Italy 1
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Trials by US State

Trials by US State for Cefotaxime Sodium
Location Trials
Virginia 1
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Clinical Trial Progress for Cefotaxime Sodium

Clinical Trial Phase

Clinical Trial Phase for Cefotaxime Sodium
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Cefotaxime Sodium
Clinical Trial Phase Trials
Completed 3
Enrolling by invitation 3
Terminated 1
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Clinical Trial Sponsors for Cefotaxime Sodium

Sponsor Name

Sponsor Name for Cefotaxime Sodium
Sponsor Trials
Xiangbei Welman Pharmaceutical Co., Ltd 2
Federal University of São Paulo 1
American Association for the Study of Liver Diseases 1
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Sponsor Type

Sponsor Type for Cefotaxime Sodium
Sponsor Trials
Other 7
Industry 3
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