Zavicefta vs. Meropenem in Hospital-Acquired Pneumonia: REPROVE trial

Zavicefta is as effective as a carbapenem in hospitalised patients with aerobic Gram-negative HAP, including VAP1,2 

Reprove Phase III trial: 879 hospitalised adults with HAP/VAP

The first randomised controlled trial to show non-inferiority, compared with a carbapenem, of an antimicrobial therapy targeting Gram-negative pathogens in HAP/VAP

Patients with favourable clinical response at TOC (%)*

Patients with favourable clinical response

Baseline pathogens: predominantly K. pneumoniae and P. aeruginosa including some ceftazidime-resistant strains. 100 patients (28%) had > 1 ceftazidime-resistant isolate.

ZAVICEFTA has a safety and tolerability profile consistent with both cephalosporins and carbapenems1,3-5

  • In Phase III clinical trials, the adverse event profile of ZAVICEFTA was similar to that seen with either best available therapy, doripenem or meropenem1,3-5
  • The most common (>5%) AEs for ZAVICEFTA were positive Direct Coombs test, nausea and diarrhoea6
  • Nausea and diarrhoea were usually mild or moderate in intensity1,3-6

Footnotes:

*Non-inferiority was concluded if the lower limit of the 95% CI was greater than –12.5%.1

†cMITT population comprised patients with minimum disease criteria but excluded patients with only non-target pathogens.1

‡The clinically evaluable population comprised patients in the cMITT population who received an adequate course of treatment and had an assessable clinical outcome within the assessment window, no protocol deviations that could affect the assessment of efficacy, and no unacceptable previous or concomitant antibiotics.1

Abbreviations:

AE, adverse event; CE, clinically evaluable; CI, confidence interval; cMITT, clinically modified intention-to-treat; HAP, hospital-acquired pneumonia; K. pneumoniae, Klebsiella pneumoniae; P. aeruginosa, Pseudomonas aeruginosa; TOC, test of cure; VAP, ventilator-associated pneumonia.

References:

1.Torres A, et al. Lancet Infect Dis 2018;18:285–95; 2. Torres A, et al. Open Forum Infect Dis 2019;6:ofz149; 3. Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9;  4. Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73; 5. Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62; 6. ZAVICEFTA. Summary of Product Characteristics

Prescribing Information

Zavicefta▼ (ceftazidime avibactam) Prescribing Information
ZAVICEFTA® 2 g/0.5 g Powder for Concentrate for Solution for Infusion
Legal Category: Prescription Only Medicine (POM)
NHS Price: 10 vial pack £857.00.
Click here for the Summary of Product Characteristics 

Meronem IV (meropenem) Prescribing Information
Meronem IV 1g 
Legal Category: Prescription Only Medicine (POM). 
NHS Price: 10 vial pack £206.28
Click here for the Summary of Product Characteristics 
Meronem IV 500mg
Legal Category: Prescription Only Medicine (POM). 
NHS Price: 10 vial pack £103.14
Click here for the Summary of Product Characteristics 

Tygacil® (tigecycline) Prescribing Information 
Tygacil® 50 mg Powder for Solution for Infusion
Legal Category: Prescription Only Medicine (POM)  
NHS Price: 10 vial pack £323.10  
Click here for the Summary of Product Characteristics 

Tazocin® (piperacillin sodium, tazobactam sodium) Prescribing information
Tazocin® 2 g/0.25 g Powder for Solution for Infusion
Legal Category: Prescription Only Medicine (POM) 
NHS Price: 1 vial pack £7.65 
Click here for the Summary of Product Characteristics 
Tazocin® 4 g/0.5 g Powder for Solution for Infusion
Legal Category: Prescription Only Medicine (POM)
NHS Price:  1 vial pack £15.17  
Click here for the Summary of Product Characteristics 

PP-ZVA-GBR-1058.  December 2020