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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER


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All Clinical Trials for Cefotaxime And Dextrose 3.9% In Plastic Container

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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefotaxime And Dextrose 3.9% In Plastic Container

Condition Name

Condition Name for Cefotaxime And Dextrose 3.9% In Plastic Container
Intervention Trials
Spontaneous Bacterial Peritonitis 4
Urinary Tract Infections 4
Cirrhosis 3
Respiratory Tract Infections 3
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Condition MeSH

Condition MeSH for Cefotaxime And Dextrose 3.9% In Plastic Container
Intervention Trials
Infections 9
Infection 8
Peritonitis 8
Communicable Diseases 6
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Clinical Trial Locations for Cefotaxime And Dextrose 3.9% In Plastic Container

Trials by Country

Trials by Country for Cefotaxime And Dextrose 3.9% In Plastic Container
Location Trials
Egypt 8
Spain 6
France 4
Sweden 2
Vietnam 2
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Trials by US State

Trials by US State for Cefotaxime And Dextrose 3.9% In Plastic Container
Location Trials
Virginia 1
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Clinical Trial Progress for Cefotaxime And Dextrose 3.9% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Cefotaxime And Dextrose 3.9% In Plastic Container
Clinical Trial Phase Trials
Phase 4 14
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cefotaxime And Dextrose 3.9% In Plastic Container
Clinical Trial Phase Trials
Completed 20
Recruiting 7
Unknown status 6
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Clinical Trial Sponsors for Cefotaxime And Dextrose 3.9% In Plastic Container

Sponsor Name

Sponsor Name for Cefotaxime And Dextrose 3.9% In Plastic Container
Sponsor Trials
Assistance Publique - Hôpitaux de Paris 2
Tanta University 2
Xiangbei Welman Pharmaceutical Co., Ltd 2
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Sponsor Type

Sponsor Type for Cefotaxime And Dextrose 3.9% In Plastic Container
Sponsor Trials
Other 50
Industry 3
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Cefotaxime and Dextrose 3.9% in Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Cefotaxime, a third-generation cephalosporin antibiotic, is widely used for treating various bacterial infections. When combined with dextrose in a plastic container, it offers a convenient and stable formulation for intravenous administration. Here, we will delve into the clinical trials, market analysis, and future projections for this formulation.

Clinical Trials Overview

Efficacy and Safety

Clinical trials have consistently shown that cefotaxime is effective and safe for treating moderate to severe bacterial infections. A notable study compared sulbactam/cefoperazone with cefotaxime and found that cefotaxime had an overall efficacy rate of 90% and a bacterial eradication rate of 81%[1].

Dosage and Administration

Cefotaxime is typically administered intravenously, with doses ranging from 1 to 2 grams, given every 6 to 8 hours. The formulation with dextrose ensures that the solution is iso-osmotic, reducing the risk of phlebitis and other local reactions[4].

Pharmacokinetics

Pharmacokinetic studies have shown that cefotaxime achieves significant serum levels after intravenous administration, with a dose-dependent increase in serum concentrations. There is no evidence of accumulation with repetitive doses, and the drug is primarily excreted through the kidneys[3].

Market Analysis

Current Market Status

Cefotaxime remains a vital antibiotic in the global market, particularly in regions where bacterial infections are prevalent. The convenience of the DUPLEX® container, which combines cefotaxime sodium with dextrose injection, has enhanced its market appeal. This formulation simplifies the reconstitution process and ensures stability of the solution for a longer period[4].

Market Trends

The increasing incidence of bacterial infections, coupled with the rise in antibiotic resistance, drives the demand for effective antibiotics like cefotaxime. The market is also influenced by regulatory approvals and import policies. For instance, the temporary importation of non-FDA approved cefotaxime formulations into the U.S. market highlights the ongoing demand and supply dynamics[2].

Competitive Landscape

The antibiotic market is highly competitive, with several third-generation cephalosporins available. However, cefotaxime's broad spectrum of activity against both gram-positive and gram-negative bacteria, along with its favorable pharmacokinetic profile, maintains its position in the market. Other competitors include ceftriaxone, which, while similar, has different indications and usage patterns[5].

Market Projections

Growth Drivers

  • Increasing Incidence of Infections: The rise in bacterial infections, especially in hospital settings, is expected to drive the demand for cefotaxime.
  • Antibiotic Resistance: The growing concern of antibiotic resistance underscores the need for effective antibiotics like cefotaxime.
  • Convenient Formulations: The DUPLEX® container formulation is likely to continue its market traction due to its ease of use and stability.

Market Challenges

  • Regulatory Hurdles: Changes in regulatory policies and import restrictions can impact the availability and pricing of cefotaxime.
  • Resistance and Side Effects: The ongoing issue of antibiotic resistance and potential side effects, such as nephrotoxicity when used with aminoglycosides, may influence prescribing patterns[3].

Future Outlook

Given the current trends, the market for cefotaxime and dextrose 3.9% in plastic containers is expected to remain stable or grow modestly. The need for effective antibiotics in both developed and developing countries will continue to drive demand. However, the market will need to adapt to evolving regulatory environments and the ongoing challenge of antibiotic resistance.

Key Takeaways

  • Clinical Efficacy: Cefotaxime has been proven effective in treating moderate to severe bacterial infections.
  • Convenient Formulation: The DUPLEX® container with dextrose ensures ease of use and stability.
  • Market Demand: The increasing incidence of bacterial infections and the need for effective antibiotics drive market demand.
  • Regulatory and Resistance Challenges: The market must navigate regulatory changes and the issue of antibiotic resistance.

FAQs

Q: What is the typical dosage of cefotaxime for adult patients?

A: The typical dosage for adult patients is 1 to 2 grams administered intravenously every 6 to 8 hours[4].

Q: How is cefotaxime formulated in the DUPLEX® container?

A: Cefotaxime is formulated with dextrose injection in a DUPLEX® container, ensuring an iso-osmotic solution that is easy to reconstitute and stable for a longer period[4].

Q: What are the common indications for cefotaxime?

A: Cefotaxime is indicated for the treatment of various bacterial infections, including those caused by susceptible gram-positive and gram-negative organisms. It is often used in cases of sepsis, meningitis, and other serious infections[3].

Q: Can cefotaxime be used in pediatric patients?

A: Yes, cefotaxime can be used in pediatric patients, with dosages adjusted based on body weight. For patients weighing less than 50 kg, the recommended daily dose is 50 to 180 mg/kg divided into four to six equal doses[4].

Q: What are the potential side effects of cefotaxime?

A: Common side effects include local reactions at the injection site, gastrointestinal disturbances, and the potential for nephrotoxicity when used with aminoglycosides. Cefotaxime can also induce a positive direct Coombs test in some patients[3].

Sources

  1. Sulbactam/Cefoperazone Versus Cefotaxime for the Treatment of Hospitalized Patients with Moderate-to-Severe Bacterial Infections. Clinical Infectious Diseases, Volume 24, Issue 3, 1997.
  2. Temporary Importation of Cefotaxime for Injection to Address Drug Shortage. FDA, 2021.
  3. Cefotaxime for Injection USP and Dextrose Injection. FDA Label, 2007.
  4. Cefotaxime for Injection - RxList. RxList.
  5. Ceftriaxone and Dextrose: Package Insert / Prescribing Info. Drugs.com.

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