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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR CEFOTAXIME

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All Clinical Trials for Cefotaxime

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00124228 Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis Completed Fondo de Investigacion Sanitaria Phase 3 2004-11-01 Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p<0.0001). These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP, associated with signs of a systemic inflammatory response, is very frequent and results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention. The objective of this project, therefore, is to evaluate if the plasma volume expansion with albumin, associated with conventional antibiotic therapy, can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis.
NCT00124228 Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis Completed Hospital Clinic of Barcelona Phase 3 2004-11-01 Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p<0.0001). These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP, associated with signs of a systemic inflammatory response, is very frequent and results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention. The objective of this project, therefore, is to evaluate if the plasma volume expansion with albumin, associated with conventional antibiotic therapy, can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis.
NCT00161330 Oral Vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT Terminated IL Sogno di Stefano Phase 3 2000-06-01 The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 Oral Vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT Terminated Regione Veneto Phase 3 2000-06-01 The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 Oral Vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT Terminated University of Padova Phase 3 2000-06-01 The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00187655 Effect of, OAT3, on the Renal Secretion of Cefotaxime Completed University of California, San Francisco Phase 1 2004-01-01 In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.
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 2007-06-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefotaxime

Condition Name

Condition Name for Cefotaxime
Intervention Trials
Urinary Tract Infections 4
Cirrhosis 2
Spontaneous Bacterial Peritonitis 2
Respiratory Tract Infections 2
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Condition MeSH

Condition MeSH for Cefotaxime
Intervention Trials
Infection 6
Peritonitis 6
Communicable Diseases 5
Urinary Tract Infections 4
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Clinical Trial Locations for Cefotaxime

Trials by Country

Trials by Country for Cefotaxime
Location Trials
Spain 6
Egypt 4
France 3
Sweden 2
Brazil 2
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Cefotaxime
Clinical Trial Phase Trials
Phase 4 12
Phase 3 6
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Cefotaxime
Clinical Trial Phase Trials
Completed 10
Recruiting 7
Not yet recruiting 4
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Clinical Trial Sponsors for Cefotaxime

Sponsor Name

Sponsor Name for Cefotaxime
Sponsor Trials
Xiangbei Welman Pharmaceutical Co., Ltd 2
Fayoum University Hospital 2
Assistance Publique - Hôpitaux de Paris 2
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Sponsor Type

Sponsor Type for Cefotaxime
Sponsor Trials
Other 38
Industry 2
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Mallinckrodt
Johnson and Johnson
Baxter

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