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# FDA Agrees to 2 Special Protocols for Basilea Antibiotic
- URL: https://www.fdaweb.com/fda-agrees-to-2-special-protocols-for-basilea-antibiotic/
- Published: 2017-04-21T12:00:00.000Z
- Updated: 2026-09-14T22:19:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138506

FDA and Basilea Pharmaceutica have reached agreement on Special Protocol Assessments (SPAs) for two planned Phase 3 clinical studies evaluating the company’s antibiotic ceftobiprole. for treating *Staphylococcus aureus* bacteremia (bloodstream infections) and acute bacterial skin and skin structure infections. If successful, the company believes studies would be cross-supportive for a U.S. registration in both indications and could separately support label extensions in other parts of the world.

  
Both studies will be multi-center, double-blind, randomized non-inferiority studies. One study will compare ceftobiprole with daptomycin in treating adult patients with *Staphylococcus aureus* bacteremia, including infective endocarditis. The FDA-agreed primary endpoint is overall success at a post-treatment visit 70 days after randomization. The other study will compare ceftobiprole with vancomycin and aztreonam in treating adult patients with acute bacterial skin and skin structure infections. The FDA-agreed primary endpoint in this study is early clinical response at 48-72 hours after beginning treatment.