ZINFORO

Key points

Favourable opinion for reimbursement in the treatment of complicated skin and soft tissue infections (cSSTI) in children from birth to 2 months of age.

What therapeutic improvement ?

Therapeutic improvement in management.

Role in the care pathway ?

In children, parenteral treatment is recommended in cellulitis with risk factors or signs of severity: an IV amoxicillin/clavulanic acid combination is the first-line treatment. This treatment should be combined with clindamycin in the event of skin infections with toxic shock syndrome, necrotising bacterial cellulitis or necrotising fasciitis, for which management is medical and surgical.

Antibiotic therapy should be adjusted following bacteriological identification. In the event of methicillin-resistant Staphylococcus aureus infection, vancomycin is the reference treatment.

Role of the medicinal product in the care pathway

ZINFORO (ceftaroline) may be proposed in healthcare-associated infections for which staphylococcal infection has been demonstrated or is suspected (suppurating infections) and for which methicillin resistance has been demonstrated or is strongly suspected, without any suggestion of previous colonisation with Pseudomonas aeruginosa. Although these are in the minority in cSSTI, it should be noted that ZINFORO has no activity on microorganisms such as Pseudomonas aeruginosa and anaerobes implicated in necrotising forms of infection.

Its prescription in the paediatric population should take into account the potential for an increased occurrence of adverse effects due to overexposure to drugs, particularly in neonates, infants, children and adolescents weighing less than 33 kg. A special warning has been added in sections 4.2 and 5.2 of the SPC.