Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.
Publication
, Journal Article
Holland, TL; Chambers, HF; Boucher, HW; Corey, GR; Coleman, R; Castaneda-Ruiz, B; Fowler, VG
Published in: Clin Infect Dis
February 15, 2019
Clinical trials for Staphylococcus aureus bloodstream infections (SAB) are broadly grouped into 2 categories: registrational trials intended to support regulatory approval of antibiotics for the treatment of SAB and strategy trials intended to inform clinicians on the best treatment options for SAB among existing antibiotics. Both types of SAB trials are urgently needed but have been limited by cost, complexity, and regulatory uncertainty. Here, we review key SAB trial design considerations for investigators, sponsors, and regulators.
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Published In
Clin Infect Dis
DOI
EISSN
1537-6591
Publication Date
February 15, 2019
Volume
68
Issue
5
Start / End Page
865 / 872
Location
United States
Related Subject Headings
- Staphylococcus aureus
- Staphylococcal Infections
- Sepsis
- Research Design
- Microbiology
- Humans
- Clinical Trials as Topic
- Anti-Bacterial Agents
- Adult
- 3202 Clinical sciences
Citation
APA
Chicago
ICMJE
MLA
NLM
Holland, T. L., Chambers, H. F., Boucher, H. W., Corey, G. R., Coleman, R., Castaneda-Ruiz, B., & Fowler, V. G. (2019). Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults. Clin Infect Dis, 68(5), 865–872. https://doi.org/10.1093/cid/ciy774
Holland, Thomas L., Henry F. Chambers, Helen W. Boucher, G Ralph Corey, Rebecca Coleman, Bibiana Castaneda-Ruiz, and Vance G. Fowler. “Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.” Clin Infect Dis 68, no. 5 (February 15, 2019): 865–72. https://doi.org/10.1093/cid/ciy774.
Holland TL, Chambers HF, Boucher HW, Corey GR, Coleman R, Castaneda-Ruiz B, et al. Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults. Clin Infect Dis. 2019 Feb 15;68(5):865–72.
Holland, Thomas L., et al. “Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.” Clin Infect Dis, vol. 68, no. 5, Feb. 2019, pp. 865–72. Pubmed, doi:10.1093/cid/ciy774.
Holland TL, Chambers HF, Boucher HW, Corey GR, Coleman R, Castaneda-Ruiz B, Fowler VG. Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults. Clin Infect Dis. 2019 Feb 15;68(5):865–872.
Published In
Clin Infect Dis
DOI
EISSN
1537-6591
Publication Date
February 15, 2019
Volume
68
Issue
5
Start / End Page
865 / 872
Location
United States
Related Subject Headings
- Staphylococcus aureus
- Staphylococcal Infections
- Sepsis
- Research Design
- Microbiology
- Humans
- Clinical Trials as Topic
- Anti-Bacterial Agents
- Adult
- 3202 Clinical sciences