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Last Updated: April 25, 2025

CLINICAL TRIALS PROFILE FOR CEFTAZIDIME


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All Clinical Trials for Ceftazidime

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ceftazidime

Condition Name

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

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

Trials by Country

Trials by Country for Ceftazidime
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
Location Trials
California 12
Ohio 9
Michigan 6
Florida 5
Texas 5
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Clinical Trial Progress for Ceftazidime

Clinical Trial Phase

Clinical Trial Phase for Ceftazidime
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
Clinical Trial Phase Trials
Completed 38
Unknown status 10
Recruiting 9
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Clinical Trial Sponsors for Ceftazidime

Sponsor Name

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

Sponsor Type for Ceftazidime
Sponsor Trials
Industry 69
Other 56
NIH 1
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Ceftazidime-Avibactam: Clinical Trials, Market Analysis, and Projections

Introduction

Ceftazidime-avibactam is a combination antibiotic consisting of the cephalosporin ceftazidime and the beta-lactamase inhibitor avibactam. This drug has been gaining significant attention for its efficacy against a wide range of Gram-negative bacteria, including those producing extended-spectrum beta-lactamases (ESBLs), AmpC, and serine carbapenemases. Here, we will delve into the recent clinical trials, market analysis, and future projections for ceftazidime-avibactam.

Clinical Trials Overview

Efficacy and Safety in Adult Populations

Several Phase 3 clinical trials have evaluated the efficacy and safety of ceftazidime-avibactam in adults with complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI)/pyelonephritis, and nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP)[1].

  • RECLAIM, REPRISE, and RECAPTURE Trials: These trials randomized patients to receive either ceftazidime-avibactam or comparator antibiotics (predominantly carbapenems) for 5-21 days. The results showed clinical cure rates of 88.1% for ceftazidime-avibactam and 88.1% for comparators in the pooled non-MBL beta-lactamase-producing population. The safety profile of ceftazidime-avibactam was consistent with previous observations[1].

  • REPROVE Trial: This trial focused on NP, including VAP, and also demonstrated favorable clinical and microbiological outcomes for ceftazidime-avibactam, with a protocol amendment increasing the dose for patients with moderate-to-severe renal impairment[1].

Pediatric Populations

A Phase 2 clinical trial (NCT02475733) evaluated the safety, efficacy, and pharmacokinetics of ceftazidime-avibactam plus metronidazole in children with cIAI. The study found that ceftazidime-avibactam plus metronidazole was well-tolerated and effective in pediatric patients, including those with ceftazidime-non-susceptible strains[4].

Market Analysis

Market Size and Trends

The global market for ceftazidime-avibactam is growing due to increasing demand for effective treatments against antibiotic-resistant Gram-negative infections. Market research reports indicate that the market size is expanding, driven by the rising incidence of carbapenem-resistant Gram-negative infections and the need for alternative antibiotics to more toxic options like colistin[2].

  • Market Data Breakdown: The market is analyzed by type, application, company, and region. The competitive landscape includes key company profiles, highlighting the major players in the ceftazidime-avibactam market[2].

Usage Patterns and Hospital Trends

A retrospective cohort study from 2015 to 2017 showed a significant increase in the use of ceftazidime-avibactam in hospitals. The study found that ceftazidime-avibactam prescriptions increased from 0.44 per 10,000 hospitalizations in 2015 to 7.7 per 10,000 in 2017, while colistin prescriptions decreased by 5% over the same period[3].

Market Projections

Growth Forecasts

The global ceftazidime-avibactam market is projected to continue growing due to several factors:

  • Increasing Resistance: The rising incidence of antibiotic-resistant infections will drive the demand for effective treatments like ceftazidime-avibactam.
  • Expanding Indications: The potential extension of labeled indications to pediatric populations and other infection types will further boost market growth[4].
  • Market Expansion: The market is expected to expand geographically, with increasing adoption in various regions due to its efficacy and safety profile[2].

Challenges and Opportunities

Despite the positive outlook, there are challenges to consider:

  • Regulatory Environment: Regulatory approvals and postapproval commitments can influence market dynamics.
  • Competition: The antibiotic market is highly competitive, with other drugs and combinations vying for market share.
  • Resistance Development: The continuous evolution of bacterial resistance poses a long-term challenge to the efficacy of ceftazidime-avibactam[3].

Key Takeaways

  • Clinical Efficacy: Ceftazidime-avibactam has demonstrated strong clinical and microbiological efficacy against a range of Gram-negative pathogens.
  • Safety Profile: The drug has a consistent safety profile, making it a viable option for various patient populations.
  • Market Growth: The market for ceftazidime-avibactam is expected to grow driven by increasing demand and expanding indications.
  • Usage Trends: Hospital trends show a progressive increase in ceftazidime-avibactam use, replacing more toxic alternatives like colistin.

FAQs

What are the primary indications for ceftazidime-avibactam?

Ceftazidime-avibactam is primarily indicated for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI)/pyelonephritis, and nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP)[1].

How does ceftazidime-avibactam compare to other antibiotics in terms of efficacy?

Ceftazidime-avibactam has shown comparable or superior efficacy to carbapenems in clinical trials, particularly against ESBLs, AmpC, and serine carbapenemase-producing Gram-negative pathogens[1].

What is the safety profile of ceftazidime-avibactam?

The safety profile of ceftazidime-avibactam is consistent with previous observations, with a low incidence of adverse events, similar to ceftazidime alone[1][4].

How is ceftazidime-avibactam used in pediatric populations?

Ceftazidime-avibactam plus metronidazole has been found to be well-tolerated and effective in pediatric patients with cIAI, including those with ceftazidime-non-susceptible strains[4].

What are the market trends and projections for ceftazidime-avibactam?

The market for ceftazidime-avibactam is growing due to increasing demand for effective treatments against antibiotic-resistant infections. The market is projected to continue expanding driven by expanding indications and geographical adoption[2][3].

Sources

  1. Efficacy and safety of ceftazidime/avibactam in patients with infections caused by ESBLs, AmpC and serine carbapenemase-producing Gram-negative pathogens. Journal of Antimicrobial Chemotherapy, 2023.
  2. Global Ceftazidime and Avibactam Sodium for Injection Market. QYResearch, 2024.
  3. Pharmacoepidemiology of Ceftazidime-Avibactam Use. Clinical Infectious Diseases, 2020.
  4. Safety and Efficacy of Ceftazidime-Avibactam Plus Metronidazole in Children with Complicated Intra-abdominal Infections. The Pediatric Infectious Disease Journal, 2019.

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