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Streamlining safety data collection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia trials: recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Abstract:

Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug dev...

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Publication status:
Published
Peer review status:
Peer reviewed
Version:
Accepted manuscript

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Publisher copy:
10.1093/cid/ciw316

Authors


Donnelly, H More by this author
Alemayehu, D More by this author
Botgros, R More by this author
Comic-Savic, S More by this author
Eisenstein, B More by this author
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Publisher:
Oxford University Press Publisher's website
Journal:
Clinical Infectious Diseases Journal website
Volume:
63
Issue:
suppl 2
Pages:
S39-S45
Publication date:
2016-08-01
Acceptance date:
2016-04-07
DOI:
EISSN:
1537-6591
ISSN:
1058-4838
Pubs id:
pubs:638410
URN:
uri:96e60540-76c3-44cc-9e98-603d088e3888
UUID:
uuid:96e60540-76c3-44cc-9e98-603d088e3888
Local pid:
pubs:638410

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