RECAPTURE

RECAPTURE: Ceftazidime-avibactam versus doripenem for the treatment of cUTI, including acute pyelonephritis1

As effective as a carbapenem in hospitalised patients with Gram-negative cUTIs1

clinical_response_test_of_cure_uti_1-new0803.jpg

An international, non-inferiority, randomised, double-blind, comparative, Phase III trial1
•     ZAVICEFTA versus doripenem

Trial population1
•     cUTI, including acute pyelonephritis 
       – Randomised patients, N=1033
       – mMITT population, N=810 

*Non-inferiority of ceftazidime-avibactam versus doripenem was demonstrated for the FDA co-primary endpoints (prespecified margin of −10%), as well for the EMA primary endpoint (prespecified margin of −12.5%). The lower limit of the 2-sided 95% CI for the treatment difference for the EMA primary endpoint was also >0%, showing superiority of ceftazidime-avibactam at the 5% significance level.
Patients in the mMITT population comprised those with minimum disease criteria and eligible baseline pathogen(s). 

Abbreviations:
AE, adverse event; CI, confidence interval; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; EMA, European Medicines Agency; HAP, hospital-acquired pneumonia; mMITT, microbiologically modified intention-to-treat; VAP, ventilator-associated pneumonia.

References:
1. Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62

Prescribing Information
Meronem IV 1g – SPC 
Legal Category: POM.       Basic NHS Cost: 10 vial pack £206.28
Meronem IV 500mg – SPC 
Legal Category: POM.       Basic NHS Cost: 10 vial pack £103.14

 

Piperacillin/tazobactam
Tazocin 2 g/0.25 g Powder for Solution for Infusion – SPC
Legal category: POM.       Basic NHS cost: 1 vial pack £7.65 
Tazocin 4  g/0.5 g Powder for Solution for Infusion – SPC
Legal category: POM.       Basic NHS cost: 1 vial pack £15.17 
 
Tygacil 50 mg Powder for Solution for Infusion – SPC
Legal Category: POM.       Basic NHS Cost: 10 vial pack £323.10
 
ZAVICEFTA® 2 g/0.5 g Powder for Concentrate for Solution for Infusion – SPC
Legal category: POM.       Basic NHS price: 10 vial pack £857.00.

PP-ZVA-GBR-0700.  October 2019