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HAP/VAP
cUTI
cIAI
Paediatrics
Bacteraemia
With mortality rates significantly higher in patients with inappropriate empirical therapy than in those with appropriate treatment (47% and 20% respectively), there is an unmet need for new, more effective treatment.10
REPROVE Phase III trial:1
879 patients hospitalised adults with HAP/VAP were randomised in a controlled setting to show noninferiority, compared with a carbapenem, of an antimicrobial therapy targeting Gram-negative pathogens in HAP/VAP.
Baseline pathogens1
Predominantly K. pneumoniae and P. aeruginosa, including some ceftazidime-resistant strains.
100 patients (28%) had ≥1 ceftazidime-resistant isolate.
Trial design
REPROVE: International, non-inferiority, randomised, double-blind, Phase III trial1
Lung penetration PK/PD data
Complementary kinetic profile with proven penetration into the lung11
Concentration–time profiles following administration of 2 g of ceftazidime + 0.5 g of avibactam
Professor of Pulmonology and Respiratory Critical Care Medicine at University of Barcelona, Spain, talks about hospital-acquired pneumonia and ventilator-associated pneumonia, as well as the REPROVE study, a Phase III randomised clinical trial comparing ceftazidime-avibactam to meropenem.
ZAVICEFTA is as effective as a carbapenem in patients with HAP/VAP caused by Gram-negative pathogens.1
In cUTI the likelihood of initial antibiotic therapy failure and serious complications, particularly the development of antimicrobial resistance, is more common compared with uncomplicated UTI.15
RECAPTURE Phase III trial:
1033 hospitalised adults with cUTI were randomised in a controlled setting to show noninferiority, compared with a carbapenem, of an antimicrobial therapy targeting Gram-negative pathogens in cUTI.
Baseline pathogens
Predominantly E, coli and K. pneumoniae, including some ceftazidime-resistant strains.
Trial design
RECAPTURE: International, non-inferiority, randomised, double-blind, Phase III trial2
Infectious Diseases Consultant at Manchester University NHS Foundation Trust, sharing his view on the challenges of MDR Gram-negative infections. Learn about his clinical practice experience in a renal transplant patient and the role of ceftazidime-avibactam in patients with cUTI.
REPRISE Phase III trial:
333 hospitalised adults with cUTI or cIAI were randomised in a controlled setting. The REPRISE study is the first pathogen directed clinical trial for ceftazidime–avibactam examining its efficacy against ceftazidime resistant Gram-negative pathogens.
Baseline pathogens
Ceftazidime-resistant Enterobacterales (most commonly E. coli or K. pneumoniae) and P. aeruginosa.
Trial design
REPRISE: Pathogen-directed, international, randomised, open-label, Phase III trial3
Example
Consultant Microbiologist at Hampshire Hospitals, discuss the REPRISE study.
ZAVICEFTA is as effective as a carbapenem in patients with cUTI and as effective as best-available therapy in cUTI or cIAI patients caused by Gram-negative pathogens.2,3
Underlying medical conditions and inadequate early antibiotic therapy are among the factors consistently associated with poor outcomes in patients with cIAIs.4,17
RECLAIM Phase III trial:
1066 hospitalised adults with cIAI were randomised in a controlled setting to show noninferiority, compared with a carbapenem, of an antimicrobial therapy targeting Gram-negative pathogens in cIAI.
Baseline pathogens
E coli, K. pneumoniae and P. aeruginosa, including some ceftazidime-resistant strains. 417 patients (40%) had polymicrobial infection at baseline.
Trial design
RECLAIM: International, non-inferiority, randomised, double-blind, comparative, Phase III programme5
REPRISE Phase III trial:
333 hospitalised adults with cUTI or cIAI were randomised in a controlled setting. The REPRISE study is the first pathogen directed clinical trial for ceftazidime–avibactam examining its efficacy against ceftazidime resistant Gram-negative pathogens.
Baseline pathogens
Predominantly E. coli and K. pneumoniae, including some ceftazidime-resistant strains.
Trial design
REPRISE: Pathogen-directed, international, randomised, open-label, Phase III trial3
Example
Consultant Microbiologist at Hampshire Hospitals, discuss the REPRISE study.
ZAVICEFTA is as effective as a carbapenem in patients with cUTI and as effective as best-available therapy in cUTI or cIAI patients caused by Gram-negative pathogens.2,3
Safe, effective treatment options are urgently needed to address the growing threat of MDR Gram-negative infections in paediatric patients.7,20
Phase II trial:
95 hospitalised paediatric patients 3 months and older with cUTI. The first randomised controlled trial of ZAVICEFTA in paediatric patients with cUTI.
Baseline pathogens
Predominantly E coli (92%)
Trial design
cUTI paediatric trial: Multicentre, single-blind, randomised, actively-controlled, Phase II trial8
Phase II trial:
83 hospitalised paediatric patients 3 months and older with cIAI. The first time randomised controlled trial of ZAVICEFTA in paediatric patients with cIAI.
Baseline pathogens
Predominantly E coli (80%) and P. aeruginosa (33%)
Trial design
cIAI paediatric trial: Multicentre, single-blind, randomised, actively-controlled, Phase II trial7
Example
ZAVICEFTA achieved favourable clinical response rates in paediatric patients aged 3 months and older with cIAI¶¶¶¶¶¶ and cUTI, with similar effectiveness to comparator therapies when assessed in paediatric trials.7,8
With mortality rates as high as 48%, new effective treatment options are needed to address the increasing threat of MDR Gram-negative bacteraemia.23,26,27
Phase III clinical trial programme:
A post-hoc analysis******* of 101 adult patients in five Phase III international, randomised, non-inferiority trials in patients with bacteraemia††††††† associated with HAP/VAP, cIAI or cUTI.9,28
Baseline pathogens9
E coli (69%), K pneumoniae (21%), P aeruginosa (17%)
Baseline diagnoses9
Acute pyelonephritis (69%), VAP (21%)
ZAVICEFTA showed favourable clinical and microbiological response rates in adult patients with bacteraemia††††††† associated with HAP/VAP, cIAI or cUTI.9,28
Learn more about ZAVICEFTA’s safety and tolerability.
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