Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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Case Reports
The Use of TKM-100802 and Convalescent Plasma in 2 Patients With Ebola Virus Disease in the United States.
The current West Africa Ebola virus disease (EVD) outbreak has resulted in multiple individuals being medically evacuated to other countries for clinical management. ⋯ It is unclear what role the experimental drug and convalescent plasma had in the recovery of these patients. Prospective clinical trials are needed to delineate the role of investigational therapies in the care of patients with EVD.
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Association of Mitral Valve Prolapse With Infective Endocarditis Due to Viridans Group Streptococci.
Although patients with certain cardiac valve abnormalities have increased risk of infective endocarditis (IE), it is unknown whether these abnormalities are associated with specific pathogens in IE cases. We report a strong association between mitral valve prolapse and viridans group streptococcal IE in a population-based cohort from Olmsted County, Minnesota.
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The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. ⋯ A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp).
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Randomized Controlled Trial Multicenter Study
Safety and immunogenicity of a Vi polysaccharide-tetanus toxoid conjugate vaccine (Typbar-TCV) in healthy infants, children, and adults in typhoid endemic areas: a multicenter, 2-cohort, open-label, double-blind, randomized controlled phase 3 study.
Enteric fever caused by Salmonella Typhi remains a major public health problem in developing countries. Typbar-TCV is a single-dose typhoid Vi polysaccharide-tetanus toxoid conjugate vaccine for persons ≥6 months of age. ⋯ CTRI/2011/08/001957, CTRI/2014/01/004341.
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Observational Study
Intravenous immunoglobulin and mortality in pneumonia patients with septic shock: an observational nationwide study.
The role of intravenous immunoglobulin (IVIG) as an adjunctive treatment for severe sepsis remains controversial. We hypothesized that IVIG could be effective for treating pneumonia patients who have septic shock. ⋯ In this large retrospective nationwide study, we found that there may be no significant association between IVIG use and mortality in mechanically ventilated pneumonia patients with septic shock.