CLINICAL TRIALS PROFILE FOR CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

All Clinical Trials for Cefotaxime And Dextrose 2.4% 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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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)

Clinical Trial Conditions for Cefotaxime And Dextrose 2.4% In Plastic Container

Condition Name

Condition Name for Cefotaxime And Dextrose 2.4% In Plastic Container
Intervention	Trials
Spontaneous Bacterial Peritonitis	4
Urinary Tract Infections	4
Cirrhosis	3

Condition MeSH

Condition MeSH for Cefotaxime And Dextrose 2.4% In Plastic Container
Intervention	Trials
Infections	9
Infection	8
Peritonitis	8

Clinical Trial Locations for Cefotaxime And Dextrose 2.4% In Plastic Container

Trials by Country

Trials by Country for Cefotaxime And Dextrose 2.4% In Plastic Container
Location	Trials
Egypt	8
Spain	6
France	4
Sweden	2
Vietnam	2

Trials by US State

Trials by US State for Cefotaxime And Dextrose 2.4% In Plastic Container
Location	Trials
Virginia	1

Clinical Trial Progress for Cefotaxime And Dextrose 2.4% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Cefotaxime And Dextrose 2.4% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Cefotaxime And Dextrose 2.4% In Plastic Container
Clinical Trial Phase	Trials
Completed	20
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for Cefotaxime And Dextrose 2.4% In Plastic Container

Sponsor Name

Sponsor Name for Cefotaxime And Dextrose 2.4% In Plastic Container
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
Tanta University	2
Xiangbei Welman Pharmaceutical Co., Ltd	2

Sponsor Type

Sponsor Type for Cefotaxime And Dextrose 2.4% In Plastic Container
Sponsor	Trials
Other	50
Industry	3

Cefotaxime and Dextrose 2.4% in Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

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

Clinical Trials and Efficacy

Bacteriological and Clinical Cure Rates

Clinical trials have demonstrated the efficacy of cefotaxime in treating bacterial infections. In multicenter trials, cefotaxime showed high bacteriological and clinical cure rates, exceeding 94% in comparative studies against other antibiotics like cefazolin[1].

Spectrum of Activity

Cefotaxime is effective against a wide range of pathogens, including Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Staphylococcus aureus, and Escherichia coli. It also shows efficacy against infections caused by Proteus, Enterobacter, and Klebsiella species, although with slightly lower success rates against Serratia marcescens and Pseudomonas aeruginosa[1].

Special Populations

Cefotaxime has been studied in various patient populations, including infants, children, and the elderly. For neonates, the drug's pharmacokinetics vary based on birth weight, but dosage adjustments are primarily based on age[5].

Market Analysis

Current Market Position

Cefotaxime is a well-established antibiotic in the global market, particularly in the treatment of serious bacterial infections such as sepsis, meningitis, and pneumonia. Its broad-spectrum activity and stability in the presence of many β-lactamases make it a preferred choice in clinical settings[4].

Market Trends

The global antibiotic market is driven by increasing bacterial resistance, which necessitates the use of broad-spectrum antibiotics like cefotaxime. The convenience of the DUPLEX® Drug Delivery System, which combines cefotaxime with dextrose in a single container, enhances its market appeal by simplifying administration and reducing preparation time[2].

Competitive Landscape

Cefotaxime competes with other cephalosporins and broad-spectrum antibiotics. However, its synergistic effects with aminoglycosides against certain strains of Pseudomonas aeruginosa and its stability against various β-lactamases give it a competitive edge[5].

Market Projections

Growth Drivers

• Increasing Resistance: The rising incidence of antibiotic-resistant bacteria is expected to drive the demand for broad-spectrum antibiotics like cefotaxime.
• Convenience and Ease of Use: The DUPLEX® system, which combines cefotaxime with dextrose, is likely to continue attracting healthcare providers due to its ease of administration.
• Expanding Indications: Clinical guidelines recommending cefotaxime for specific procedures, such as liver transplantation, will further boost its market presence[4].

Challenges

• Antibiotic Resistance: The ongoing issue of antibiotic resistance may lead to reduced efficacy over time, necessitating continuous monitoring and potential adjustments in treatment protocols.
• Regulatory Scrutiny: Strict regulations to curb the misuse of antibiotics and prevent resistance could impact market growth.
• Competition: The introduction of new antibiotics and alternative treatments may pose a competitive threat.

Dosage and Administration

Adult Dosage

For adults, cefotaxime is typically administered intravenously or intramuscularly at doses ranging from 1 to 2 grams every 6 to 8 hours, depending on the severity of the infection[4].

Pediatric Dosage

For infants, children, and adolescents, the dosage is adjusted based on age and weight, typically 50 mg/kg/dose every 6 hours, with a maximum dose of 2 grams[4].

Special Considerations

Patients with renal insufficiency require dose adjustments to avoid accumulation and potential toxicity. Additionally, caution is advised when administering cefotaxime to patients with a history of gastrointestinal disease or to nursing mothers[2].

Safety and Side Effects

Common Side Effects

Common side effects include gastrointestinal disturbances, allergic reactions, and local reactions at the injection site. Serious side effects, such as increased nephrotoxicity when combined with aminoglycosides, must be carefully monitored[3].

Drug Interactions

Cefotaxime can interact with other medications, such as aminoglycosides and probenecid, which can alter its pharmacokinetics. It may also induce a positive direct Coombs test in some patients[3].

Key Takeaways

• High Efficacy: Cefotaxime demonstrates high bacteriological and clinical cure rates across various infections.
• Broad Spectrum: It is effective against a wide range of bacterial pathogens.
• Convenient Formulation: The DUPLEX® system enhances ease of administration.
• Market Growth: Driven by increasing antibiotic resistance and expanding clinical indications.
• Safety Considerations: Requires careful monitoring for side effects and drug interactions.

FAQs

Q: What is the typical dosage of cefotaxime for adults?

A: For adults, cefotaxime is typically administered intravenously or intramuscularly at doses ranging from 1 to 2 grams every 6 to 8 hours, depending on the severity of the infection[4].

Q: Is cefotaxime effective against all types of bacterial infections?

A: Cefotaxime is highly effective against many gram-positive and gram-negative bacteria, but it has limited efficacy against certain strains of Serratia marcescens and Pseudomonas aeruginosa[1].

Q: Can cefotaxime be used in pediatric patients?

A: Yes, cefotaxime can be used in pediatric patients, with dosages adjusted based on age and weight. The typical dosage is 50 mg/kg/dose every 6 hours, with a maximum dose of 2 grams[4].

Q: What are the common side effects of cefotaxime?

A: Common side effects include gastrointestinal disturbances, allergic reactions, and local reactions at the injection site. Serious side effects, such as increased nephrotoxicity when combined with aminoglycosides, must be carefully monitored[3].

Q: How does cefotaxime interact with other medications?

A: Cefotaxime can interact with other medications, such as aminoglycosides and probenecid, which can alter its pharmacokinetics. It may also induce a positive direct Coombs test in some patients[3].

Sources

1. Clinical trials of cefotaxime for the treatment of bacterial infections of the lower respiratory tract. PubMed.
2. Cefotaxime for Injection USP and Dextrose Injection in the DUPLEX® Drug Delivery System. FDA Label.
3. CLAFORAN® Sterile (cefotaxime for injection, USP) and Injection. FDA Label.
4. Claforan - Drug Summary. PDR.Net.
5. CLAFORAN® Sterile (cefotaxime for injection, USP) and Injection. FDA Label.