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Generated: November 15, 2018

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CLINICAL TRIALS PROFILE FOR CEFOTAXIME

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Clinical Trials for Cefotaxime

Trial ID Title Status Sponsor Phase Summary
NCT00124228 Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis Completed Fondo de Investigacion Sanitaria Phase 3 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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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 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 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 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)
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cefotaxime

Condition Name

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

Condition MeSH for Cefotaxime
Intervention Trials
Peritonitis 6
Infection 5
Urinary Tract Infections 4
Communicable Diseases 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 2
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 11
Phase 3 6
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Cefotaxime
Clinical Trial Phase Trials
Completed 10
Recruiting 6
Enrolling by invitation 3
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Clinical Trial Sponsors for Cefotaxime

Sponsor Name

Sponsor Name for Cefotaxime
Sponsor Trials
Xiangbei Welman Pharmaceutical Co., Ltd 2
Assistance Publique - Hôpitaux de Paris 2
Tanta University 1
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Sponsor Type

Sponsor Type for Cefotaxime
Sponsor Trials
Other 35
Industry 2
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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Covington
Deloitte
Boehringer Ingelheim
US Army
Merck
QuintilesIMS
Chubb
Fuji

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