Advisory statement on likely place in therapy

Advisory statement on likely place in therapy

Oritavancin may be an option for adults needing treatment in hospital, ambulatory care or through outpatient parental antimicrobial therapy (OPAT) for severe ABSSSI (cellulitis or erysipelas, abscesses and wound infections) when standard oral and intravenous antibiotics are not suitable. Take account of local antimicrobial resistance and seek specialist microbiological advice. Follow recommendations on new antimicrobials in the NICE guideline on antimicrobial stewardship.

Rationale

ABSSSI are common bacterial infections that may require systemic antibiotics, surgical management, and hospitalisation. The most common bacteria associated with ABSSSI is Staphylococcus aureus (S.aureus). Resistance has been reported in S. aureus, such as meticillin-resistant S. aureus (MRSA), where choice of treatment can be challenging (European public assessment report [EPAR] on oritavancin).

Evidence from 2 phase-3, randomised controlled trials in non-UK hospitals (n=968 and n=1,019) found oritavancin was non-inferior to vancomycin for treating ABSSSI caused by gram-positive pathogens in adults. Oritavancin was administered as a single 3-hour infusion and vancomycin was administered twice daily over 7 to 10 days.

The infections treated in the studies were cellulitis or erysipelas, abscesses, and wound infections. The median lesion area was between 225 cm2 and 309 cm2 and people had at least 2 signs of systemic infection, indicating that the infections were severe.

Oritavancin offers the potential for treating skin infections caused by gram-positive pathogens, including MRSA. There is no known cross-resistance between oritavancin and non-glycopeptide classes of antibiotics. Also, oritavancin does not require any dose adjustment for age, weight, or mild to moderate renal function. Therapeutic drug monitoring is not required and it is administered as a single dose treatment course (summary of product characteristics [SPC] for oritavancin).

The NICE guideline on antimicrobial stewardship makes recommendations on the effective use of new antimicrobials. Oritavancin should be reserved for those people most likely to benefit from it, after specialist microbiological advice to help monitor use and limit antimicrobial resistance.