See Full Prescribing Information for complete boxed warning. An increased risk of death was seen in the SIRTURO treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial. Only use SIRTURO when an effective treatment regimen cannot otherwise be provided. QT prolongation can occur with SIRTURO. Use with drugs that prolong the QT interval may cause additive QT prolongation.
A decline in antibacterial drug development coupled with emerging bacterial resistance has resulted in limited treatment options. One of the challenges facing antibacterial drug development is appropriate clinical trial designs. Noninferiority trials are appropriate to study new antibacterial drugs for the treatment of serious diseases; superiority trials can be challenging and cannot be the only acceptable trial design to study antibacterial drugs. Our efforts must continue to make new therapies available to meet patient needs.
Identification of reliable, reproducible, and precise end points for future studies of hospital-acquired and ventilator-associated pneumonia is of paramount importance for approval of new therapeutic agents. As required by the Code of Federal Regulations 21 CFR 314.126, the methods of assessment of a subject's response (ie, end points) must be well defined and reliable. The study protocol and results should explain the variables measured, the methods of observation, and criteria used to assess response. Meeting these requirements has proven to be problematic in clinical trials for the evaluation of new products for the treatment of hospital-acquired and ventilator-associated pneumonia because of the subjectivity of assessing a clinical response end point. There are multiple issues and caveats to consider when selecting appropriate end points for these trials.
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