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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR CEFTAZIDIME IN DEXTROSE CONTAINER


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All Clinical Trials for Ceftazidime In Dextrose Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00173901 ↗ Adverse Drug Reactions of Different Brands of Ceftazidime Injection Unknown status National Taiwan University Hospital Phase 4 2001-03-01 The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.
NCT00210964 ↗ Ceftobiprole in Hospital Acquired Pneumonia Completed Basilea Pharmaceutica Phase 3 2005-04-01 The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
NCT00229008 ↗ Ceftobiprole in Hospital Acquired Pneumonia Completed Basilea Pharmaceutica Phase 3 2005-11-01 The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
NCT00333385 ↗ Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis Terminated Baxter Healthcare Corporation Phase 4 2001-10-01 The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
NCT00333385 ↗ Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis Terminated GlaxoSmithKline Phase 4 2001-10-01 The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
NCT00333385 ↗ Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis Terminated Roche Pharma AG Phase 4 2001-10-01 The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
NCT00333385 ↗ Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis Terminated Vaincre la Mucoviscidose Phase 4 2001-10-01 The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ceftazidime In Dextrose Container

Condition Name

Condition Name for Ceftazidime In Dextrose Container
Intervention Trials
Cystic Fibrosis 5
Pneumonia 5
Complicated Intra-abdominal Infection 4
Healthy 3
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Condition MeSH

Condition MeSH for Ceftazidime In Dextrose Container
Intervention Trials
Infections 20
Infection 18
Communicable Diseases 17
Pneumonia 10
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Clinical Trial Locations for Ceftazidime In Dextrose Container

Trials by Country

Trials by Country for Ceftazidime In Dextrose Container
Location Trials
United States 94
China 24
Japan 18
Spain 13
India 13
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Trials by US State

Trials by US State for Ceftazidime In Dextrose Container
Location Trials
California 12
Ohio 9
Michigan 6
Florida 5
Texas 5
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Clinical Trial Progress for Ceftazidime In Dextrose Container

Clinical Trial Phase

Clinical Trial Phase for Ceftazidime In Dextrose Container
Clinical Trial Phase Trials
Phase 4 14
Phase 3 15
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Ceftazidime In Dextrose Container
Clinical Trial Phase Trials
Completed 38
Unknown status 10
Recruiting 9
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Clinical Trial Sponsors for Ceftazidime In Dextrose Container

Sponsor Name

Sponsor Name for Ceftazidime In Dextrose Container
Sponsor Trials
Pfizer 24
AstraZeneca 17
Forest Laboratories 7
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Sponsor Type

Sponsor Type for Ceftazidime In Dextrose Container
Sponsor Trials
Industry 69
Other 56
NIH 1
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Ceftazidime in Dextrose Container: Clinical Trials, Market Analysis, and Projections

Introduction

Ceftazidime, a third-generation cephalosporin antibiotic, is widely used in the treatment of various bacterial infections. When administered in a dextrose container, it offers a convenient and stable formulation for intravenous use. Here, we will delve into the clinical trials, market analysis, and projections for ceftazidime in dextrose containers.

Clinical Trials and Efficacy

Indications and Usage

Ceftazidime in dextrose containers is indicated for the treatment of a broad range of infections, including lower respiratory tract infections, intra-abdominal infections, and central nervous system infections. It is effective against a variety of bacteria, including Pseudomonas aeruginosa, Haemophilus influenzae, and Staphylococcus aureus (methicillin-susceptible isolates)[1][4].

Empiric Therapy and Combination Treatments

Clinical trials have shown that ceftazidime can be used successfully as empiric therapy in cases of suspected or confirmed sepsis and in combination with other antibiotics such as aminoglycosides, vancomycin, and clindamycin. This versatility makes it a valuable option in severe and life-threatening infections, particularly in immunocompromised patients[3].

Central Nervous System Infections

Ceftazidime has been used effectively in the treatment of meningitis caused by Haemophilus influenzae and Neisseria meningitidis. It has also shown efficacy in limited cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae[1].

Stability and Compatibility

Container Types and Stability

Studies have compared the stability of ceftazidime in different container types. Ceftazidime solutions are more stable in glass bottles than in polypropylene (PP) or polyvinyl chloride (PVC) containers. However, PP containers show better stability than PVC containers[2].

Compatibility with IV Fluids

Ceftazidime is compatible with a wide range of intravenous fluids, including 0.9% Sodium Chloride Injection, 5% Dextrose Injection, and others. It maintains satisfactory potency for up to 24 hours at room temperature or 7 days under refrigeration in these solutions. However, it is less stable in Sodium Bicarbonate Injection and should not be used with this diluent[3].

Market Analysis

Market Demand

The demand for ceftazidime in dextrose containers is driven by its broad spectrum of activity and the convenience of its formulation. Hospitals and healthcare facilities prefer this formulation due to its ease of use and stability, which reduces the risk of medication errors.

Competitive Landscape

The market for cephalosporin antibiotics is competitive, with several brands offering ceftazidime formulations. However, the unique dual-chamber design of the DUPLEX® Container, which combines ceftazidime with dextrose, offers a distinct advantage in terms of convenience and stability.

Regulatory Considerations

Regulatory bodies such as the FDA closely monitor the quality and stability of ceftazidime formulations. For instance, B. Braun Medical Inc. issued a voluntary recall of one lot of ceftazidime in dextrose containers due to out-of-specification results for high molecular weight polymers, highlighting the importance of strict quality control measures[5].

Market Projections

Growth Drivers

The market for ceftazidime in dextrose containers is expected to grow driven by several factors:

  • Increasing Incidence of Bacterial Infections: The rise in antibiotic-resistant bacteria and the need for effective treatments will continue to drive demand.
  • Convenience and Stability: The dual-chamber formulation offers ease of use and stability, making it a preferred choice in clinical settings.
  • Expanding Healthcare Infrastructure: Growing healthcare infrastructure in developing countries will increase the demand for reliable and effective antibiotic formulations.

Market Challenges

Despite the growth drivers, the market faces several challenges:

  • Antibiotic Resistance: The increasing resistance to antibiotics, including cephalosporins, poses a significant challenge.
  • Regulatory Scrutiny: Strict regulatory requirements and the risk of recalls due to quality issues can impact market stability.
  • Competition: The competitive landscape with multiple brands offering similar formulations can make market penetration challenging.

Key Takeaways

  • Broad Spectrum of Activity: Ceftazidime in dextrose containers is effective against a wide range of bacterial infections.
  • Stability and Compatibility: The formulation is stable in various IV fluids and offers convenience in clinical use.
  • Market Growth: The market is expected to grow driven by increasing demand for effective antibiotic treatments and the expanding healthcare infrastructure.
  • Regulatory and Competitive Challenges: The market faces challenges from antibiotic resistance, regulatory scrutiny, and competition from other brands.

FAQs

Q1: What are the primary indications for ceftazidime in dextrose containers?

Ceftazidime in dextrose containers is primarily indicated for the treatment of lower respiratory tract infections, intra-abdominal infections, and central nervous system infections.

Q2: Can ceftazidime be used in combination with other antibiotics?

Yes, ceftazidime can be used concomitantly with other antibiotics such as aminoglycosides, vancomycin, and clindamycin in severe and life-threatening infections.

Q3: How stable is ceftazidime in different container types?

Ceftazidime is most stable in glass bottles, followed by polypropylene (PP) containers, and least stable in polyvinyl chloride (PVC) containers.

Q4: What are the recommended dosages for patients with renal impairment?

For patients with renal impairment, the dosage of ceftazidime should be reduced based on creatinine clearance. For example, patients with creatinine clearance between 50-31 mL/min should receive 1 gram every 12 hours, and those with clearance between 30-16 mL/min should receive 1 gram every 24 hours[1][4].

Q5: Are there any specific precautions to be taken during the administration of ceftazidime in dextrose containers?

Yes, precautions include avoiding the use of plastic containers in series connections to prevent air embolism and ensuring the solution is clear and the container is intact before administration[1][4].

Sources

  1. Drugs.com: Ceftazidime and Dextrose: Package Insert / Prescribing Info.
  2. PubMed: Comparison of Ceftazidime Degradation in Glass Bottles and Plastic Containers.
  3. RxList: Ceptaz (Ceftazidime): Side Effects, Uses, Dosage, Interactions.
  4. FDA: CEFTAZIDIME for Injection USP and DEXTROSE Injection USP.
  5. FDA: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container.

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