期刊
CLINICAL INFECTIOUS DISEASES
卷 55, 期 8, 页码 1114-1121出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/cis566
关键词
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资金
- National Cancer Institute [HHSN261200800001E]
- National Institute of Allergy and Infectious Diseases, National Institutes of Health
- Actelion Pharmaceuticals
- Basilea Pharmaceutica International
- Cempra Pharmaceuticals
- Cerexa
- Actelion
- Basilea
- Bayer
- Cempra
- Durata
- Cubist-Calixa
- FAB Pharma
- JJ
- Kalidex
- Meiji
- Merada
- Merck
- Nabriva
- Wyeth/Pfizer
Efficacy endpoints for previous registrational trials of antimicrobials for acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP) were based on nonstandardized, clinician-based observations and decisions, as well as on patient reports. More quantifiable, reproducible, and externally verifiable endpoints could improve the design of future noninferiority trials. At the request of the Food and Drug Administration, the Foundation for the National Institutes of Health convened a broadly representative scientific project team to evaluate potential endpoints for such registrational trials. Review of historical and modern data led to the conclusion that antimicrobial treatment effects are most apparent early in therapy; later outcomes provide important supportive information. Although evidence is incomplete, early response endpoints can anchor noninferiority hypotheses in ABSSSI and CABP registrational trials, thereby allowing evidence-based drug development to continue. Further research is underway to establish which short- and long-term outcomes are well-defined, reliable, and reflective of how patients feel, function, or survive.
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