US panel endorses non-inferiority studies for complicated skin infections

Thursday 20 November 2008
Sue Sutter - Washington Editor

A US FDA advisory panel has overwhelmingly endorsed the use of non-inferiority studies for antibiotics to treat complicated skin and skin structure infections (cSSSI) but not for uncomplicated infections (uSSSI).

Members of the anti-infective drugs advisory committee generally agreed a non-inferiority margin of about 10% was appropriate for cSSSI studies enrolling patients with wound infections and cellulitis. Patients with diabetic foot infections should be studied separately from the rest of the cSSSI population.

Patients with abscesses should undergo separate evaluation, perhaps in superiority trials, owing to less historical evidence of antibiotic efficacy in this population...


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