ZAVICEFTA is indicated for the treatment of adult and paediatric patients aged 3 months and older with the following infections:¹

- Complicated urinary tract infection (cUTI),  including pyelonephritis
- Complicated intra-abdominal infection (cIAI)
- Hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP)
- Infections due to aerobic Gram-negative organisms in patients with limited treatment options†

ZAVICEFTA demonstrated similar effectiveness to comparator therapies (meropenem or cefepime) when assessed in paediatric trials*^2,3

ZAVICEFTA has a similar safety and tolerability profile in paediatric patients aged 3 months and older with cIAI and cUTI to that observed in adults*^1-3

The safety assessment in paediatric patients is based on data from two trials in which 61 patients with cIAI and 67 patients with cUTI aged 3 months to < 18 years received ZAVICEFTA¹

† Data support the use of ZAVICEFTA in adult patients with Limited Treatment Options including in primary bacteraemia, cSSTI, BJI, meningitis, febrile neutropenia, cystic fibrosis, post-transplant patients due to KPC and OXA-48 resistance mechanisms, and MDR Pseudomonas.^4-18

* ZAVICEFTA has been evaluated in paediatric patients aged 3 months to < 18 years in two Phase II single-blind, randomised, comparative clinical studies, one in patients with cIAI and one in patients with cUTI (N=128). In the cIAI trial, patients received ZAVICEFTA plus metronidazole, and in the cUTI trial, patients received ZAVICEFTA alone. The primary objective in each study was to assess safety and tolerability of ZAVICEFTA (+/- metronidazole). Secondary objectives included assessment of pharmacokinetics and efficacy; efficacy was a descriptive endpoint in both studies.^{1,2,3​​​​​​​}